Data / Medical devices / United States / Apyx Medical Corporation
Apyx Medical Corporation: FDA-registered device maker in Clearwater, FL, United States, 22 510(k) clearances
Apyx Medical Corporation is registered with the FDA (registration 3007593903) in Clearwater, FL, United States. It lists 6 device types. The FDA files 22 510(k) clearances under its listings, the newest dated August 21, 2026. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007593903
- Address
- 5115 Ulmerton Rd, Clearwater, FL, United States, 33760
- Owner or operator
- Apyx Medical Corporation (9910100)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- October 5, 2007
- Registered through
- 2026
- Brand names listed
- A2350, A3350, APYX-044-BPS Renuvion/J-Plasma Precise Open 44mm a.k.a: BVX-044-BPS Renuvion/J-Plasma Precise Open 44mm, APYX-044-BPS Renuvion/J-Plasma Precise Open 44mm, a.k.a BVX-044-BPS Renuvion/J-Plasma Precise Open 44mm, APYX-1253B Monopolar Footswitch, APYX-1254B Bipolar Footswitch, APYX-150-BPP Renuvion/J-Plasma Precise Open 150mm a.k.a: BVX-150-BPP Renuvion/J-Plasma Precise Open 150mm, APYX-150-BPS Renuvion/J-Plasma Precise Open 150mm a.k.a: BVX-150-BPS Renuvion/J-Plasma Precise Open 150mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Scrub, Operating-Room | GEC | 1 | Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Cautery, Thermal, Battery-Powered | HQP | 2 | Contract manufacturer | accessdata.fda.gov |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 21, 2026 | K261710 | AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors | QPB | Substantially Equivalent | Apyx Medical Corporation | accessdata.fda.gov |
| May 8, 2026 | K253396 | AYON Body Contouring System (AYON SYSTEM) | QPB | Substantially Equivalent | Apyx Medical Corporation | accessdata.fda.gov |
| May 12, 2025 | K244050 | AYON Body Contouring System (AYON SYSTEM) | QPB | Substantially Equivalent | Apyx Medical Corporation | accessdata.fda.gov |
| June 9, 2023 | K230586 | Renuvion® Micro Handpiece | GEI | Substantially Equivalent | Apyx Medical Corporation | accessdata.fda.gov |
| April 27, 2023 | K230272 | Renuvion® APR Handpiece | GEI | Substantially Equivalent | Apyx Medical Corporation | accessdata.fda.gov |
| October 11, 2022 | K221830 | Apyx One Console | GEI | Substantially Equivalent | Apyx Medical Corporation | accessdata.fda.gov |
| May 25, 2022 | K211652 | Renuvion Dermal Handpiece, Renuvion Dermal System | GEI | Substantially Equivalent | Apyx Medical Corporation (Formerly Bovie Medical Corporation | accessdata.fda.gov |
| January 4, 2021 | K202880 | J-Plasma Precise FLEX Handpiece | GEI | Substantially Equivalent | Apyx Medical Corporation (Formerly Bovie Medical Corporation | accessdata.fda.gov |
| October 31, 2019 | K192867 | Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) | GEI | Substantially Equivalent | Bovie Medical Corporation Dba Apyx Medical Corporation | accessdata.fda.gov |
| October 11, 2019 | K191542 | Apyx Plasma/RF Handpiece | GEI | Substantially Equivalent | Bovie Medical Corporation Dba Apyx Medical Corporation | accessdata.fda.gov |
| July 30, 2019 | K191484 | Renuvion/J-Plasma Precise Handpiece | GEI | Substantially Equivalent | Apyx Medical Corporation(Formerly Bovie Medical Corporation) | accessdata.fda.gov |
| March 12, 2019 | K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces | GEI | Substantially Equivalent | Bovie Medical Corporation | accessdata.fda.gov |
| May 1, 2017 | K170777 | Bovie J-Plasma Precise FLEX Handpiece | GEI | Substantially Equivalent | Bovie Medical Corporation | accessdata.fda.gov |
| March 8, 2017 | K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator | GEI | Substantially Equivalent | Bovie Medical Corporation | accessdata.fda.gov |
| August 4, 2015 | K151325 | Bovie J-Plasma Handpiece | GEI | Substantially Equivalent | Bovie Medical Corporation | accessdata.fda.gov |
| December 12, 2014 | K142975 | Bovie Ultimate High Frequency Electrosurgical Generator | GEI | Substantially Equivalent | Bovie Medical Corporation | accessdata.fda.gov |
| November 24, 2009 | K092761 | PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C | GEI | Substantially Equivalent | Bio Protech, Inc. | accessdata.fda.gov |
| December 22, 2000 | K001955 | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 | GEI | Substantially Equivalent | Aaron Medical Industries | accessdata.fda.gov |
| April 19, 2000 | K000961 | AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE | GEI | Substantially Equivalent | Aaron Medical Industries | accessdata.fda.gov |
| January 30, 1995 | K945765 | HIGH TEMPERATURE CAUTERY | GEI | Substantially Equivalent | Aaron Medical Industries | accessdata.fda.gov |
| January 30, 1995 | K945764 | HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP | KNS | Substantially Equivalent | Aaron Medical Industries | accessdata.fda.gov |
| January 30, 1995 | K945760 | HIGH TEMPERATURE CAUTERY | GEI | Substantially Equivalent | Aaron Medical Industries | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 1, 2021 | 87274 | Class II | Ongoing | Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. | There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration. | accessdata.fda.gov |
| April 20, 2020 | 85597 | Class II | Terminated | Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ab | Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use. | accessdata.fda.gov |
| June 18, 2018 | 80544 | Class II | Terminated | J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surg | There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue. | accessdata.fda.gov |
| February 8, 2018 | 79398 | Class II | Terminated | J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS | Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused. | accessdata.fda.gov |
| July 18, 2016 | 74790 | Class II | Terminated | BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures. | The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip. | accessdata.fda.gov |
| June 29, 2004 | 29487 | Not yet classified | Terminated | Battery-operated Cautery Low Temperature, fine/elongated Tip | The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of System, Suction, Lipoplasty For Removal
- All makers of Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- All makers of Unit, Cautery, Thermal, Battery-Powered
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Brush, Scrub, Operating-Room
Updated August 21, 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.