Data / FDA device clearances / General, Plastic Surgery
General, Plastic Surgery device clearances: 992
The full list. FDA general, plastic surgery device clearances and approvals: 992 rows for $49.60, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 41 rows a month. The new rows come each week by email, $19 a month.
Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.
For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery, and every list with its row count and price is at https://specstream.ai/data/lists.json.
Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).
FDA made 992 device decisions in general, plastic surgery (FDA review panel) from November 12, 2024 to October 30, 2026: 737 510(k) clearances and De Novo grants and 255 PMA approvals and supplements, for 498 applicants. The newest, K263063 on October 30, 2026, is B`orze Inc Laser Family (Sorren/Adonis) from Borze, Inc..
The request: Every new FDA clearance or approval of a general, plastic surgery device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.
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.
- 992Decisions
- 737510(k) and De Novo
- 255PMA
- October 30, 2026Latest decision
Newest decisions
The newest 100 of 992, 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 | K263063 | B`orze Inc Laser Family (Sorren/Adonis) | Borze, Inc. | Idaho | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| October 30, 2026 | K260306 | RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit... | Smith & Nephew Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OMP | accessdata.fda.gov |
| October 28, 2026 | K262343 | Dynavisc | Fziomed, Inc. | California | Substantially Equivalent | 510(k) traditional | OWW | accessdata.fda.gov |
| October 28, 2026 | K261636 | Microwave Ablation Antennas | Canyon Medical, Inc. | China | Substantially Equivalent | 510(k) traditional | NEY | accessdata.fda.gov |
| October 28, 2026 | K261630 | GI Windows Flexagon Plus OTOLoc System | GI Windows Surgical | Massachusetts | Substantially Equivalent | 510(k) traditional | SAH | accessdata.fda.gov |
| October 28, 2026 | K260310 | HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown... | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | QSO | accessdata.fda.gov |
| October 27, 2026 | K263461 | Tendon Anchor | Smith & Nephew, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | GDW | accessdata.fda.gov |
| October 27, 2026 | K262349 | Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI) | Risu Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| October 27, 2026 | K260520 | Skin Clinic Nitro Clear for Warts and Skin Tags | Cryoconcepts LP | Pennsylvania | Substantially Equivalent | 510(k) traditional | GEH | accessdata.fda.gov |
| October 26, 2026 | P250034/S004 | Optune Pax | Novocure, GmbH | 30-day notice accepted | PMA 30-day notice | SHC | accessdata.fda.gov | |
| October 26, 2026 | K262984 | Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06... | Shenzhen Bway Tech Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OHS | accessdata.fda.gov |
| October 26, 2026 | K262720 | SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max) | Single Pass, Inc. | California | Substantially Equivalent | 510(k) traditional | GEI | accessdata.fda.gov |
| October 26, 2026 | K262627 | Fractional CO2 Laser Therapy System (Z121) | Sanhe PERFECTLASER Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| October 23, 2026 | P990075/S071 | Saline-Filled and Spectrum Breast Implants | Mentor Worldwide, LLC | California | 30-day notice accepted | PMA 30-day notice | FWM | accessdata.fda.gov |
| October 23, 2026 | P220024/S007 | LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation (HMF) Device; LIQUIFIX Precision Open Hernia Mesh Fixation... | Advanced Medical Solutions Limited | Approved | PMA 180-day supplement | PLJ | accessdata.fda.gov | |
| October 23, 2026 | P060028/S063 | MemoryShape Breast Implants | Mentor Worldwide, LLC | California | 30-day notice accepted | PMA 30-day notice | FTR | accessdata.fda.gov |
| October 23, 2026 | P030053/S093 | MemoryGel Breast Implants | Mentor Corp. | California | 30-day notice accepted | PMA 30-day notice | FTR | accessdata.fda.gov |
| October 23, 2026 | K262752 | Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OHS | accessdata.fda.gov |
| October 23, 2026 | K261982 | RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747) | Smith & Nephew Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OMP | accessdata.fda.gov |
| October 22, 2026 | K262701 | PicoPeak Picosecond Nd:Yag Laser System (Bella-9) | Beijing Sea Heart International Science and Technologyco.Ltd | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| October 21, 2026 | P990075/S070 | MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES | Mentor Worldwide, LLC | California | 30-day notice accepted | PMA 30-day notice | FWM | accessdata.fda.gov |
| October 21, 2026 | P250016/S006 | Belotero Intense (+) Lidocaine Dermal Filler | Merz North America, Inc. | North Carolina | 30-day notice accepted | PMA 30-day notice | LMH | accessdata.fda.gov |
| October 21, 2026 | K263319 | ACHM30 AtriClip FLEX-Mini LAA Exclusion System | AtriCure, Inc. | Ohio | Substantially Equivalent | 510(k) special | PZX | accessdata.fda.gov |
| October 21, 2026 | K261252 | Versius Surgical System (Versius Plus) | Cmr Surgical Limited | United Kingdom | Substantially Equivalent | 510(k) traditional | SCV | accessdata.fda.gov |
| October 20, 2026 | K262628 | Picosecond Laser treatment system (Z180) | Sanhe PERFECTLASER Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| October 20, 2026 | K262386 | SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch... | Stryker Instruments | Michigan | Substantially Equivalent | 510(k) traditional | GEI | accessdata.fda.gov |
| October 19, 2026 | K262932 | AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3) | Shenzhen Accompany Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OHS | accessdata.fda.gov |
| October 16, 2026 | K262443 | Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) | Sofradim Production | France | Substantially Equivalent | 510(k) traditional | OWT | accessdata.fda.gov |
| October 16, 2026 | K262284 | KIM BLUE | Desarrollo e Investigación Médica Aragonesa S.L. | Spain | Substantially Equivalent | 510(k) traditional | OTN | accessdata.fda.gov |
| October 14, 2026 | P160042/S032 | Revanesse Versa, Revanesse Versa+ (with lidocaine) and Revanesse Lips+ (with lidocaine) | Prollenium Medical Technologies, Inc. | 30-day notice accepted | PMA 30-day notice | LMH | accessdata.fda.gov | |
| October 14, 2026 | K262885 | 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) | Guangxi Hope Medical Devices Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | FTC | accessdata.fda.gov |
| October 13, 2026 | K261572 | Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) | Keyue (Hangzhou) Medical Information Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| October 13, 2026 | K252288 | TECAR Therapy Device (TC2000, TC2001) | Shenzhen Dongdixin Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | PBX | accessdata.fda.gov |
| October 9, 2026 | K262352 | IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OHT | accessdata.fda.gov |
| October 8, 2026 | P250021/S002 | saypha® ChiQ | Croma-Pharma GmbH | Approved | PMA 180-day supplement | LMH | accessdata.fda.gov | |
| October 8, 2026 | K262346 | CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight... | Wuhan Phomed Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| October 8, 2026 | K260426 | MeCare Alpha (MCA2019) | IVT Medical, Ltd. | Israel | Substantially Equivalent | 510(k) traditional | OMP | accessdata.fda.gov |
| October 7, 2026 | P250021/S001 | saypha® ChiQ | Croma-Pharma GmbH | Approved | PMA 180-day supplement | LMH | accessdata.fda.gov | |
| October 7, 2026 | K262822 | Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) | Zhongshan GL Electronics Co. , Ltd. | China | Substantially Equivalent | 510(k) traditional | BTA | accessdata.fda.gov |
| October 7, 2026 | K261692 | Diode Laser Hair Removal Machine (QDTM-03) | Beijing Nubway S&T Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| October 5, 2026 | K262285 | UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35) | Shijiazhuang Recovery Star Medical Device Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | FTC | accessdata.fda.gov |
| October 2, 2026 | P230005/S002 | Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone... | Motiva USA, LLC | California | Approved | PMA 180-day supplement | FTR | accessdata.fda.gov |
| September 30, 2026 | K261975 | Braun Aura 7 (6041) | CyDen Limited | United Kingdom | Substantially Equivalent | 510(k) special | OHT | accessdata.fda.gov |
| September 29, 2026 | P800002/S036 | Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web Webber | C.R. Bard, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | LMF | accessdata.fda.gov |
| September 29, 2026 | P020056/S064 | Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Implants | Allergan | California | Approved | PMA 180-day supplement | FTR | accessdata.fda.gov |
| September 29, 2026 | K263073 | Fast Absorbing PGLA | Riverpoint Medical, LLC | Oregon | Substantially Equivalent | 510(k) special | GAM | accessdata.fda.gov |
| September 28, 2026 | K261543 | Phasix ST Parastomal Hernia Mesh | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | Rhode Island | Substantially Equivalent | 510(k) traditional | OWT | accessdata.fda.gov |
| September 28, 2026 | K260474 | Liora Monofilament Scaffold | TELA Bio, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | FTL | accessdata.fda.gov |
| September 25, 2026 | P230005/S005 | Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants | Motiva USA, LLC | California | Approved | PMA 135-day supplement | FTR | accessdata.fda.gov |
| September 25, 2026 | K261977 | Braun Aura 9 (6042) | Cyden Limited | United Kingdom | Substantially Equivalent | 510(k) special | OHT | accessdata.fda.gov |
| September 25, 2026 | K254291 | easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic... | Ezisurg Medical Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GDW | accessdata.fda.gov |
| September 24, 2026 | K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| September 22, 2026 | K243223 | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) | Bh Group Us, LLC | Florida | Substantially Equivalent | 510(k) traditional | PBX | accessdata.fda.gov |
| September 19, 2026 | K252723 | Dynamis Pro Family | Fotona D.O.O. | Slovenia | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| September 19, 2026 | K241973 | SmartIPL_NI System | Lumenis Be, Ltd. | Israel | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| September 18, 2026 | P990004/S080 | SURGIFOAM® Absorbable Gelatin Sponge | Ferrosan Meidcal Devices A/S | Approved | PMA 180-day supplement | LMF | accessdata.fda.gov | |
| September 18, 2026 | P900033/S117 | INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft... | Integra Lifesciences Corp. | New Jersey | 30-day notice accepted | PMA 30-day notice | MGR | accessdata.fda.gov |
| September 18, 2026 | P850010/S119 | Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent- Fibrillar... | Integra LifeSciences Corporation | New Jersey | 30-day notice accepted | PMA 30-day notice | LMF | accessdata.fda.gov |
| September 18, 2026 | P810006/S115 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent... | Integra LifeSciences Corporation | New Jersey | 30-day notice accepted | PMA 30-day notice | LMF | accessdata.fda.gov |
| September 18, 2026 | P140029/S058 | Restylane® Contour | Q-Med AB | Approved | PMA 180-day supplement | LMH | accessdata.fda.gov | |
| September 18, 2026 | K262524 | Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) | ONE BEAUTY Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | OHT | accessdata.fda.gov |
| September 18, 2026 | K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| September 18, 2026 | K254238 | MINT MONO Sutures | Hans Biomed Corporation | South Korea | Substantially Equivalent | 510(k) traditional | NEW | accessdata.fda.gov |
| September 18, 2026 | K254160 | VacHeal Negative Pressure Wound Therapy System | VacHeal, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | OKO | accessdata.fda.gov |
| September 17, 2026 | P030050/S056 | SCULPTRA® (injectable poly-L Lactic acid) | Q-Med AB | 30-day notice accepted | PMA 30-day notice | LMH | accessdata.fda.gov | |
| September 17, 2026 | K262073 | Hygienic Protective Bite Cover (2207-010-50) | Dürr Dental SE | Germany | Substantially Equivalent | 510(k) traditional | PEM | accessdata.fda.gov |
| September 17, 2026 | K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch... | Stryker Instruments | Michigan | Substantially Equivalent | 510(k) special | GEI | accessdata.fda.gov |
| September 17, 2026 | K261817 | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| September 17, 2026 | K261673 | LED Therapy Device (QLXY-01) | Beijing Nubway S&T Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| September 17, 2026 | K260677 | Vessel Closure Device (VCD177213P) | Vcd Medical S.R.L. | Italy | Substantially Equivalent | 510(k) traditional | FZP | accessdata.fda.gov |
| September 17, 2026 | K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | Puerto Rico | Substantially Equivalent | 510(k) traditional | GEI | accessdata.fda.gov |
| September 16, 2026 | K262877 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser... | Olympus Surgical Technologies America | Massachusetts | Substantially Equivalent | 510(k) special | GEX | accessdata.fda.gov |
| September 16, 2026 | K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | Gt Metabolic Solutions, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | SAH | accessdata.fda.gov |
| September 15, 2026 | K261070 | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | Colorado | Substantially Equivalent | 510(k) traditional | GEI | accessdata.fda.gov |
| September 13, 2026 | K262526 | Safety lancet (XL) | Tianjin Huahong Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | FMK | accessdata.fda.gov |
| September 11, 2026 | K262007 | PRIMED AAMI Level 3 Open Back Gowns | PRIMED Medical Products, Inc. | Canada | Substantially Equivalent | 510(k) traditional | QPC | accessdata.fda.gov |
| September 11, 2026 | K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | OMP | accessdata.fda.gov |
| September 11, 2026 | K254185 | Potenza Prime | Jeisys Medical Incorporated | South Korea | Substantially Equivalent | 510(k) traditional | GEI | accessdata.fda.gov |
| September 10, 2026 | P250020/S005 | Belotero Volume (+) Lidocaine Dermal Filler | Merz North America, Inc. | North Carolina | 30-day notice accepted | PMA 30-day notice | LMH | accessdata.fda.gov |
| September 10, 2026 | K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| September 10, 2026 | K261562 | Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| September 10, 2026 | K254246 | LT Antibacterial Foam with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | NAD | accessdata.fda.gov |
| September 8, 2026 | K261956 | Dental Barriers and Sleeves (AB0006) | ANI Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | PEM | accessdata.fda.gov |
| September 5, 2026 | K254135 | LipoSurg ARTIST | Nouvag AG | Switzerland | Substantially Equivalent | 510(k) traditional | QPB | accessdata.fda.gov |
| September 3, 2026 | P170012/S032 | HEMOBLAST Bellows | Dilon Technologies, Inc. | Virginia | Approved | PMA 180-day supplement | PMX | accessdata.fda.gov |
| September 3, 2026 | K262315 | NeuroBlate System | Monteris Medical | Minnesota | Substantially Equivalent | 510(k) traditional | ONO | accessdata.fda.gov |
| September 2, 2026 | K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | Serpex Medical | California | Substantially Equivalent | 510(k) traditional | GEH | accessdata.fda.gov |
| September 2, 2026 | K262364 | Ellian Enigma RF Device | Ellian Corp | Texas | Substantially Equivalent | 510(k) traditional | GEI | accessdata.fda.gov |
| September 2, 2026 | K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| September 1, 2026 | K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| September 1, 2026 | K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple... | PRIMED Medical Products, Inc. | Canada | Substantially Equivalent | 510(k) traditional | QSO | accessdata.fda.gov |
| August 31, 2026 | P250016/S004 | Belotero® Intense (+) Lidocaine | Merz North America, Inc. | North Carolina | Approved | PMA 180-day supplement | LMH | accessdata.fda.gov |
| August 31, 2026 | P170002/S059 | RHA 2, RHA 3, RHA 4 | Teoxane S.A. | 30-day notice accepted | PMA 30-day notice | LMH | accessdata.fda.gov | |
| August 31, 2026 | K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask... | Kam Yuen Plastic Products , Ltd. | China | Substantially Equivalent | 510(k) traditional | OHS | accessdata.fda.gov |
| August 28, 2026 | P170002/S058 | RHA 2, RHA 3, RHA 4 | Teoxane S.A. | 30-day notice accepted | PMA 30-day notice | LMH | accessdata.fda.gov | |
| August 28, 2026 | P110033/S102 | Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm | Allergan | California | 30-day notice accepted | PMA 30-day notice | LMH | accessdata.fda.gov |
| August 28, 2026 | P050047/S107 | Juvéderm Ultra XC, and Juvéderm Ultra Plus XC | Allergan | California | 30-day notice accepted | PMA 30-day notice | LMH | accessdata.fda.gov |
| August 28, 2026 | K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | NUV | accessdata.fda.gov |
| August 27, 2026 | P240035/S004 | ETHIZIA Hemostatic Patch | ETHICON, Inc. | New Jersey | Approved | PMA 180-day supplement | SGV | accessdata.fda.gov |
| August 27, 2026 | K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
Applicants with the most decisions
| Applicant | Decisions | Latest |
|---|---|---|
| Merz North America, Inc. | 44 | October 21, 2026 |
| ETHICON, Inc. | 29 | August 27, 2026 |
| Allergan | 28 | September 29, 2026 |
| Mentor Worldwide, LLC | 21 | October 23, 2026 |
| Mentor Corp. | 19 | October 23, 2026 |
| Q-Med AB | 15 | September 18, 2026 |
| Teoxane S.A. | 14 | August 31, 2026 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | 14 | June 16, 2026 |
| Ferrosan Meidcal Devices A/S | 13 | September 18, 2026 |
| Shenzhen Ulike Smart Electronics Co., Ltd. | 11 | May 21, 2026 |
| Integra LifeSciences Corporation | 9 | September 18, 2026 |
| Wontech Co., Ltd. | 9 | December 19, 2025 |
| Zhengzhou PZ Laser Slim Technology Co., Ltd. | 8 | September 17, 2026 |
| Tianjin Huahong Technology Co., Ltd. | 8 | September 13, 2026 |
| Beijing Nubway S&T Co., Ltd. | 7 | October 7, 2026 |
| Tiger Aesthetics Medical, LLC | 7 | August 7, 2026 |
| Davol Inc., Sub. C. R. Bard, Inc. | 7 | July 15, 2026 |
| Smith & Nephew Medical, Ltd. | 6 | October 30, 2026 |
| Ethicon Endo-Surgery, LLC | 6 | September 17, 2026 |
| Baxter Healthcare Corporation | 6 | August 7, 2026 |
By decision type
| Decision type | Decisions | Latest |
|---|---|---|
| 510(k) traditional | 619 | October 30, 2026 |
| PMA 30-day notice | 161 | October 26, 2026 |
| 510(k) special | 109 | October 27, 2026 |
| PMA 180-day supplement | 45 | October 23, 2026 |
| PMA real-time process supplement | 16 | July 27, 2026 |
| PMA 135-day supplement | 14 | September 25, 2026 |
| PMA original approval | 8 | July 9, 2026 |
| PMA panel track supplement | 7 | June 25, 2026 |
| 510(k) abbreviated | 5 | July 10, 2026 |
| De Novo | 4 | July 21, 2026 |
| PMA special supplement | 4 | January 14, 2026 |
By state or country
| State or country | Decisions | Latest |
|---|---|---|
| China | 249 | October 28, 2026 |
| California | 114 | October 28, 2026 |
| South Korea | 68 | September 24, 2026 |
| New Jersey | 46 | September 18, 2026 |
| Massachusetts | 39 | October 28, 2026 |
| Wisconsin | 37 | June 26, 2026 |
| Israel | 25 | October 8, 2026 |
| Florida | 20 | September 22, 2026 |
| United Kingdom | 19 | October 30, 2026 |
| North Carolina | 18 | October 21, 2026 |
| Germany | 17 | September 17, 2026 |
| Italy | 17 | September 17, 2026 |
| Illinois | 17 | August 11, 2026 |
| Rhode Island | 14 | September 28, 2026 |
| Canada | 13 | September 11, 2026 |
| Pennsylvania | 12 | October 27, 2026 |
| Taiwan | 12 | August 25, 2026 |
| Ohio | 11 | October 21, 2026 |
| Texas | 10 | September 2, 2026 |
| Tennessee | 10 | August 18, 2026 |
| New York | 10 | July 10, 2026 |
| France | 9 | October 16, 2026 |
| Spain | 9 | October 16, 2026 |
| Switzerland | 9 | September 5, 2026 |
| Georgia | 8 | October 28, 2026 |
Where FDA publishes these decisions
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. Spot a wrong value? Write to [email protected] with the link to this page.