# FDA Ophthalmic device clearances: 378 since Nov 2024

Updated October 30, 2026.

FDA made 378 device decisions in ophthalmic (FDA review panel) from November 15, 2024 to October 30, 2026: 81 510(k) clearances and De Novo grants and 297 PMA approvals and supplements, for 89 applicants. The newest, P810031/S083 on October 30, 2026, is Healon EndoCoat ™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon... from Johnson & Johnson Surgical Vision, Inc..

## The full list

FDA ophthalmic device clearances and approvals: 378 rows for $18.90, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 16 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/panel/ophthalmic

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 378
- 510(k) and De Novo: 81
- PMA: 297
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 378, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | P810031/S083 | Healon EndoCoat ™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet ™ PRO II Dual Pack... | Johnson & Johnson Surgical Vision, Inc. | California | Approved | PMA real-time process supplement | LZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P810031S083) |
| October 30, 2026 | P190018/S050 | Clareon Vivity Pro Extended Vision IOLs | Alcon Laboratories, LLC | Texas | Approved | PMA 180-day supplement | POE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190018S050) |
| October 28, 2026 | K260311 | Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview 60 UV toric (Omafilcon... | St. shine Optical Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | LPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260311) |
| October 27, 2026 | P240038/S004 | FINEVISION HP Trifocal IOLs | Beaver Visitec International, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240038S004) |
| October 27, 2026 | K261740 | Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV) | Robotrak Technologies Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | MYC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261740) |
| October 23, 2026 | P910056/S067 | enVista® Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910056S067) |
| October 23, 2026 | P240005/S010 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S010) |
| October 23, 2026 | P200020/S013 | ClearView™ HD intraocular lens (IOL) | Lenstec, Inc. | Florida | Approved | PMA 180-day supplement | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200020S013) |
| October 23, 2026 | P100016/S028 | CT LUCIA Intraocular Lenses (IOLs) | Carl Zeiss Meditec Production, LLC | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100016S028) |
| October 23, 2026 | K253875 | OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric... | Visco Vision, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | LPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253875) |
| October 22, 2026 | P160055/S058 | RxSight Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | California | 30-day notice accepted | PMA 30-day notice | PZK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160055S058) |
| October 19, 2026 | P990080/S067 | TECNIS Foldable Acrylic IOL with OptiEdge, Model ZA9003 | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990080S067) |
| October 19, 2026 | P980040/S186 | SENSAR 3-Piece Monofocal IOL, SENSAR 1-piece IOL, TECNIS Multi-focal 1-pc, TECNIS 1-PC OptiBlue IOL, TECNIS... | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980040S186) |
| October 19, 2026 | P080010/S032 | TECNIS Multi-focal 3-pc, Model ZMA00 | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080010S032) |
| October 16, 2026 | P040045/S147 | VISTAKON® (senofilcon A) Brand Contact Lenses | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S147) |
| October 16, 2026 | K262941 | Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens | Bausch + Lomb, Inc. | New York | Substantially Equivalent | 510(k) traditional | LPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262941) |
| October 15, 2026 | K262097 | MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) | Carl Zeiss Meditec Cataract Technologies | Nevada | Substantially Equivalent | 510(k) special | HQC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262097) |
| October 14, 2026 | P910056/S066 | enVista® Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910056S066) |
| October 14, 2026 | P240005/S009 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S009) |
| October 8, 2026 | P040045/S146 | VISTAKON (SENOFILCON A) Brand Contact Lenses | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S146) |
| October 1, 2026 | P890047/S072 | PROVISC™ Ophthalmic Viscosurgical Device | Alcon Research, Ltd. | Texas | 30-day notice accepted | PMA 30-day notice | LZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P890047S072) |
| October 1, 2026 | P840064/S094 | VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscosurgical System; DISCOVISC™ Ophthalmic... | Alcon Laboratories | Texas | 30-day notice accepted | PMA 30-day notice | LZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840064S094) |
| October 1, 2026 | P170043/S023 | Glaukos® iStent inject® W Trabecular Micro-Bypass System, Glaukos® iStent inject® W Trabecular Micro-Bypass... | Glaukos Corporation | California | 30-day notice accepted | PMA 30-day notice | OGO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170043S023) |
| September 30, 2026 | P910056/S064 | enVista® Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910056S064) |
| September 30, 2026 | P240005/S008 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S008) |
| September 30, 2026 | P230012/S012 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System | Alcon Research, LLC | California | 30-day notice accepted | PMA 30-day notice | LPO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230012S012) |
| September 30, 2026 | P220030/S012 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System | Alcon Research, LLC | California | 30-day notice accepted | PMA 30-day notice | LPO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220030S012) |
| September 29, 2026 | P910056/S065 | enVista Aspire™ Hydrophobic Acrylic Intraocular Lens (IOL) | Bausch & Lomb, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910056S065) |
| September 25, 2026 | P240038/S003 | FINEVISION HP Trifocal IOLs | Beaver Visitec International, Inc. | Massachusetts | Approved | PMA real-time process supplement | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240038S003) |
| September 24, 2026 | P060011/S045 | RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X | Rayner Intraocular Lenses , Ltd. |  | Approved | PMA panel track supplement | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060011S045) |
| September 18, 2026 | K262637 | SLIT LAMP SL-D4 (Type: LED) | Topcon Corporation | Japan | Substantially Equivalent | 510(k) traditional | HJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262637) |
| September 17, 2026 | K262495 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | Japan | Substantially Equivalent | 510(k) traditional | LPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262495) |
| September 14, 2026 | P170035/S021 | Bausch + Lomb Ultra (samfilcon A) Contact Lenses | Bausch and Lomb, Inc., | New York | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170035S021) |
| September 11, 2026 | K261255 | KOWA FM-600 | Kowa Company, Ltd. Chofu Factory | Japan | Substantially Equivalent | 510(k) traditional | MYC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261255) |
| September 11, 2026 | K261019 | ANTERION | Heidelberg Engineering GmbH | Germany | Substantially Equivalent | 510(k) traditional | OBO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261019) |
| September 3, 2026 | P910056/S063 | enVista hydrophobic acrylic intraocular lens | Bausch & Lomb, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910056S063) |
| September 3, 2026 | P240005/S007 | enVista Envy™ hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S007) |
| September 3, 2026 | P160055/S056 | RxSight Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | California | Approved | PMA real-time process supplement | PZK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160055S056) |
| September 3, 2026 | P060022/S038 | Akreos posterior chamber intraocular lens | Bausch & Lomb, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060022S038) |
| September 2, 2026 | P080011/S204 | BIOFINITY (COMFILCON A) | CooperVision, Inc. | California | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080011S204) |
| September 2, 2026 | P040045/S145 | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S145) |
| August 28, 2026 | P000046/S032 | Ophthalmic Viscosurgical Device Family | Anika Therapeutics, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | LZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000046S032) |
| August 18, 2026 | K262479 | TearCare System | Sight Sciences, Inc. | California | Substantially Equivalent | 510(k) special | ORZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262479) |
| August 17, 2026 | P190018/S051 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre- Loaded Delivery System, Clareon... | Alcon Laboratories, LLC | Texas | Approved | PMA 180-day supplement | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190018S051) |
| August 17, 2026 | P100016/S027 | CT LUCIA 602, CT LUCIA 202, CT LUCIA 611P, CT LUCIA 621P | Carl Zeiss Meditec Production, LLC | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100016S027) |
| August 13, 2026 | K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | Japan | Substantially Equivalent | 510(k) traditional | LPN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253795) |
| August 12, 2026 | P240005/S005 | enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular... | Bausch & Lomb, Inc. | New York | Approved | PMA special supplement | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S005) |
| August 6, 2026 | P100016/S026 | CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P | Carl Zeiss Meditec Production, LLC | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100016S026) |
| August 5, 2026 | P220015 | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens | Tianjin MasterVision Technology Co., Ltd. |  | Approved | PMA original approval | NUU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220015) |
| August 4, 2026 | P890047/S070 | PROVISC Ophthalmic Viscosurgical Device | Alcon Research, Ltd. | Texas | Approved | PMA 180-day supplement | LZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P890047S070) |
| August 4, 2026 | P840064/S092 | VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System. | Alcon Laboratories | Texas | Approved | PMA 180-day supplement | LZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840064S092) |
| July 28, 2026 | P810031/S082 | Healon PRO, Healon GV PRO and Healon5 PRO Ophthalmic Viscosurgical Devices (OVD) | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | LZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P810031S082) |
| July 24, 2026 | K261312 | Temporary Keratoprosthesis (QuickSet TKP™) | Eyekon Medical, Inc. | Florida | Substantially Equivalent | 510(k) traditional | MLP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261312) |
| July 23, 2026 | P980040/S184 | SENSARTM 1-Piece IOL, AAB00; TECNISTM 1-Piece IOL with TECNIS Simplicity™ Delivery System, DCB00; TECNISTM... | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980040S184) |
| July 22, 2026 | P910056/S062 | enVista® Hydrophobic Acrylic Intraocular Lens (IOL); enVista® Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910056S062) |
| July 22, 2026 | P240005/S006 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S006) |
| July 14, 2026 | P210005/S010 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | California | Approved | PMA 180-day supplement | POE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210005S010) |
| July 8, 2026 | P930014/S164 | AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems | Alcon Laboratories, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930014S164) |
| July 7, 2026 | P080011/S203 | comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear | CooperVision, Inc. | California | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080011S203) |
| July 7, 2026 | K261812 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily... | HOYA Lamphun , Ltd. | Thailand | Substantially Equivalent | 510(k) special | MVN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261812) |
| July 6, 2026 | P930014/S163 | Acrosof Posterior Chamber Intraocular Lens | Alcon Laboratories, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930014S163) |
| July 6, 2026 | P190018/S053 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic... | Alcon Laboratories, LLC | Texas | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190018S053) |
| July 6, 2026 | P040020/S120 | AcrySof ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL | Alcon Research, Ltd. | Texas | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040020S120) |
| July 2, 2026 | P930014/S165 | AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems | Alcon Laboratories, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930014S165) |
| July 2, 2026 | P190018/S054 | Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic... | Alcon Laboratories, LLC | Texas | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190018S054) |
| July 2, 2026 | P190018/S052 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic... | Alcon Laboratories, LLC | Texas | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190018S052) |
| July 2, 2026 | P040020/S121 | AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. | Texas | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040020S121) |
| July 2, 2026 | P040020/S119 | AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL | Alcon Research, Ltd. | Texas | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040020S119) |
| July 2, 2026 | K253704 | iPredict-DR | iHealthscreen, Inc. | New York | Substantially Equivalent | 510(k) traditional | PIB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253704) |
| July 1, 2026 | P060004/S010 | MEL 90 Excimer Laser | Carl Zeiss Meditec, Inc. | California | Approved | PMA real-time process supplement | LZS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060004S010) |
| June 26, 2026 | P160055/S054 | RxSight Light Adjustable Lens; Light Delivery Device | Rxsight, Inc. | California | Approved | PMA 180-day supplement | PZK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160055S054) |
| June 22, 2026 | K253176 | TearView | Beyond 700 Pty, Ltd. | Australia | Substantially Equivalent | 510(k) traditional | HKI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253176) |
| June 16, 2026 | P080011/S202 | comflicon A Soft (Hydrophilic) Contact Lenses for Extended Wear | CooperVision, Inc. | California | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080011S202) |
| June 10, 2026 | P100016/S025 | CT LUCIA 602, CT LUCIA 202, CT LUCIA 611P, CT LUCIA 621P | Carl Zeiss Meditec Production, LLC | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100016S025) |
| June 10, 2026 | K261174 | RxSight® Insertion Device | Rxsight, Inc. | California | Substantially Equivalent | 510(k) special | MSS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261174) |
| June 8, 2026 | P160055/S055 | RxSight Light Adjustable Lens; Light Delivery Device | Rxsight, Inc. | California | Approved | PMA real-time process supplement | PZK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160055S055) |
| June 4, 2026 | P170034/S018 | Hydrus® Microstent | Alcon Research, LLC | Texas | 30-day notice accepted | PMA 30-day notice | OGO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170034S018) |
| June 3, 2026 | P990080/S066 | TECNIS™ 3-Piece Acrylic Monofocal, Model ZA9003 | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990080S066) |
| June 3, 2026 | P980040/S183 | SENSAR™ 3-Piece Monofocal IOL, Models, AR40e, AR40E, AR40M, AR40MN | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980040S183) |
| June 3, 2026 | P080010/S031 | TECNIS™ 3-Piece Multifocal, Model ZMA00 | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080010S031) |
| May 29, 2026 | P010019/S087 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | Alcon Laboratories, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010019S087) |
| May 29, 2026 | K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | INTEROJO, Inc. | South Korea | Substantially Equivalent | 510(k) traditional | LPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260507) |
| May 28, 2026 | P230012/S011 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System | Alcon Research, LLC | California | 30-day notice accepted | PMA 30-day notice | LPO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230012S011) |
| May 28, 2026 | P220030/S011 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System | Alcon Research, LLC | California | 30-day notice accepted | PMA 30-day notice | LPO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220030S011) |
| May 26, 2026 | P150040/S024 | VISUMAX 800 Femtosecond Laser | Carl Zeiss Meditec, Inc. | California | Approved | PMA real-time process supplement | OTL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150040S024) |
| May 21, 2026 | K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft... | Pegavision Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | LPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253352) |
| May 20, 2026 | P150040/S025 | Visumax Femtosecond Laser | Carl Zeiss Meditec, Inc. | California | 30-day notice accepted | PMA 30-day notice | OTL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150040S025) |
| May 19, 2026 | P980040/S182 | TECNIS Eyhance™ Toric II IOLs with SmartLOAD™ Delivery Technology (GIU150-600) | Johnson & Johnson Surgical Vision, Inc. | California | Approved | PMA real-time process supplement | MJP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980040S182) |
| May 19, 2026 | K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft... | Pegavision Corporation | Taiwan | Substantially Equivalent | 510(k) special | LPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261299) |
| May 15, 2026 | P190018/S046 | Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL) | Alcon Laboratories, LLC | Texas | Approved | PMA 180-day supplement | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190018S046) |
| May 15, 2026 | K261264 | Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™... | Bausch and Lomb | Missouri | Substantially Equivalent | 510(k) special | HQC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261264) |
| May 7, 2026 | K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | Germany | Substantially Equivalent | 510(k) traditional | OBO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253837) |
| May 4, 2026 | P080011/S201 | Biofinity Sphere; Biofinity XR Sphere; Biofinity Energys; Biofinity Toric; Biofinity XR Toric; Biofinity... | CooperVision, Inc. | California | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080011S201) |
| May 4, 2026 | P040045/S144 | VISTAKON® (senofilcon A) contact lenses | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S144) |
| April 30, 2026 | P930014/S161 | AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL... | Alcon Laboratories, Inc. | Texas | Approved | PMA 180-day supplement | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930014S161) |
| April 30, 2026 | P900066/S017 | ISPAN Perfluoropropane C3F8 Gas | Airgas Therapeutics, LLC | Pennsylvania | 30-day notice accepted | PMA 30-day notice | LPO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P900066S017) |
| April 30, 2026 | P190018/S048 | Clareon Aspheric Hydrophobic Acrylic IOL (SY60WF); Clareon Aspheric UV Absorbing IOL (CC60WF); Clareon Toric... | Alcon Laboratories, LLC | Texas | Approved | PMA 180-day supplement | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190018S048) |
| April 30, 2026 | P060004/S011 | MEL 90 Excimer Laser | Carl Zeiss Meditec, Inc. | California | 30-day notice accepted | PMA 30-day notice | LZS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060004S011) |
| April 30, 2026 | K252455 | FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. | South Dakota | Substantially Equivalent | 510(k) traditional | QQJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252455) |
| April 29, 2026 | P040045/S143 | VISTAKON® (senofilcon A) Contact Lenses | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S143) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| CooperVision, Inc. | 41 | September 2, 2026 |
| Johnson & Johnson Surgical Vision, Inc. | 40 | October 30, 2026 |
| Bausch & Lomb, Inc. | 28 | October 23, 2026 |
| Alcon Research, LLC | 25 | September 30, 2026 |
| Alcon Laboratories, Inc. | 24 | July 8, 2026 |
| Alcon Laboratories, LLC | 16 | October 30, 2026 |
| Rxsight, Inc. | 16 | October 22, 2026 |
| Alcon Research, Ltd. | 15 | October 1, 2026 |
| Carl Zeiss Meditec, Inc. | 10 | July 1, 2026 |
| Vistakon, Division of Johnson & Johnson Vision Car | 9 | October 16, 2026 |
| Rayner Intraocular Lenses , Ltd. | 9 | September 24, 2026 |
| Lenstec, Inc. | 8 | October 23, 2026 |
| Carl Zeiss Meditec Production, LLC | 7 | October 23, 2026 |
| Alcon Laboratories | 6 | October 1, 2026 |
| Pegavision Corporation | 5 | May 21, 2026 |
| Euclid Vision Corporation | 5 | April 2, 2026 |
| The Cooper Companies | 5 | December 11, 2025 |
| Glaukos Corporation | 4 | October 1, 2026 |
| Heidelberg Engineering GmbH | 4 | September 11, 2026 |
| Acu Focus, Inc. | 4 | July 14, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 207 | October 27, 2026 |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 72 | October 28, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 45 | October 30, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 29 | October 30, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 8 | October 15, 2026 |
| [PMA panel track supplement](https://specstream.ai/data/fda-clearances/decision/pma-panel-track-supplement) | 5 | September 24, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 5 | March 20, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 3 | August 12, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 3 | August 5, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 1 | September 25, 2025 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 171 | October 30, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 67 | October 30, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 24 | October 23, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 22 | October 23, 2026 |
| [Taiwan](https://specstream.ai/data/fda-clearances/country/taiwan) | 16 | October 28, 2026 |
| [Japan](https://specstream.ai/data/fda-clearances/country/japan) | 8 | September 18, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 7 | October 27, 2026 |
| [Germany](https://specstream.ai/data/fda-clearances/country/germany) | 7 | September 11, 2026 |
| [Virginia](https://specstream.ai/data/fda-clearances/state/virginia) | 5 | April 2, 2026 |
| Nevada | 4 | October 15, 2026 |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 3 | October 27, 2026 |
| [South Korea](https://specstream.ai/data/fda-clearances/country/south-korea) | 3 | May 29, 2026 |
| [Australia](https://specstream.ai/data/fda-clearances/country/australia) | 2 | June 22, 2026 |
| [Missouri](https://specstream.ai/data/fda-clearances/state/missouri) | 2 | May 15, 2026 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 2 | April 30, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 2 | April 1, 2026 |
| [India](https://specstream.ai/data/fda-clearances/country/india) | 2 | December 12, 2025 |
| [Switzerland](https://specstream.ai/data/fda-clearances/country/switzerland) | 2 | November 14, 2025 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 2 | February 11, 2025 |
| Thailand | 1 | July 7, 2026 |
| South Dakota | 1 | April 30, 2026 |
| [Israel](https://specstream.ai/data/fda-clearances/country/israel) | 1 | April 7, 2026 |
| Idaho | 1 | February 10, 2026 |
| [France](https://specstream.ai/data/fda-clearances/country/france) | 1 | February 6, 2026 |
| [Brazil](https://specstream.ai/data/fda-clearances/country/brazil) | 1 | January 16, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).