Data / Medical devices / Hungary / Tapaszto Optic Ltd.
Tapaszto Optic Ltd.: FDA-registered device maker in Kecskemet Bacs-Kiskun, Hungary, 25 510(k) clearances and 3 PMA approvals
Tapaszto Optic Ltd. is registered with the FDA (registration 3002296055) in Kecskemet Bacs-Kiskun, Hungary. It lists 5 device types. The FDA files 25 510(k) clearances and 3 PMA approvals under its listings, the newest dated November 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002296055
- Address
- Csanyi J. krt. 8., Kecskemet Bacs-Kiskun, Hungary, 6000
- Owner or operator
- Tapaszto Optic Ltd. (10051370)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- March 8, 2016
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia | QIT | 3 | Exporter to the US | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Exporter to the US | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 29, 2021 | K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| December 11, 2018 | K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| July 13, 2016 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| March 28, 2016 | K160212 | ACUVUE (senofilcon C) Soft Contact Lens | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| February 13, 2015 | K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| January 29, 2014 | K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| August 30, 2013 | K131378 | SUS (STENFILCON A) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| July 26, 2013 | K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER | MVN | Substantially Equivalent | Sauflon Pharmaceuticals, Ltd. | accessdata.fda.gov |
| May 30, 2013 | K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| February 21, 2013 | K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| June 5, 2012 | K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| March 30, 2012 | K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| January 5, 2010 | K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| June 16, 2009 | K082880 | EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS | LPL | Substantially Equivalent | I-See Vision Technology, Inc. | accessdata.fda.gov |
| March 3, 2008 | K073485 | VISTAKON (NARAFILCON) A SOFT CONTACT LENS | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| November 22, 2006 | K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | MVN | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| November 1, 2006 | K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| June 22, 2006 | K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | MVN | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| December 6, 2005 | K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| March 28, 2005 | K050213 | FRESHLOOK ONE-DAY COLOR CONTACT LENS | MVN | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| October 28, 2004 | K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| May 16, 2002 | K020927 | BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| April 16, 2002 | K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 | FPA | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| February 26, 2002 | K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| March 6, 2000 | K000384 | FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 15, 2019 | P180035 | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear | QIT | 34 | February 17, 2026 | accessdata.fda.gov |
| October 11, 2001 | P010019 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | LPM | 83 | May 29, 2026 | accessdata.fda.gov |
| April 24, 1984 | P830037 | DURASOFT(R) 3 FOR EXT WEAR | LPM | 50 | November 8, 2012 | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lenses, Soft Contact, Extended Wear
- All makers of Set, Administration, Intravascular
Updated February 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.