Apyx Medical Corporation
Clearwater, FL, US
Apyx Medical Corporation appears in FDA device records in Clearwater, FL. FDA records list 75 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 17 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Apyx Medical Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Aaron Medical Industries510(k), recall
- Bovie Medical Corporation510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 75FDA records hold 75 510(k) clearances for Apyx Medical Corporation between 1990 and 2026. The busiest year on record is 1995, with 15. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 3 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 15 |
| 1997 | 6 |
| 1998 | 6 |
| 1999 | 3 |
| 2000 | 3 |
| 2002 | 3 |
| 2003 | 1 |
| 2006 | 4 |
| 2008 | 4 |
| 2009 | 3 |
| 2010 | 2 |
| 2012 | 2 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253396 | AYON Body Contouring System™ (AYON SYSTEM) | QPB | Substantially Equivalent | |
| K244050 | AYON Body Contouring System (AYON SYSTEM) | QPB | Substantially Equivalent | |
| K230586 | Renuvion® Micro Handpiece | GEI | Substantially Equivalent | |
| K230272 | Renuvion® APR Handpiece | GEI | Substantially Equivalent | |
| K223262 | Renuvion® APR Handpiece | GEI | Substantially Equivalent | |
| K221830 | Apyx One Console | GEI | Substantially Equivalent | |
| K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces | GEI | Substantially Equivalent | |
| K180211 | Freezpoint | GEH | Substantially Equivalent | |
| K170777 | Bovie J-Plasma Precise FLEX Handpiece | GEI | Substantially Equivalent | |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator | GEI | Substantially Equivalent | |
| K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating | GEI | Substantially Equivalent | |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator | GEI | Substantially Equivalent | |
| K152777 | Bovie Disposable Bipolar Ablator | GEI | Substantially Equivalent | |
| K152570 | Bovie J-Plasma Precise 360 Handpiece | GEI | Substantially Equivalent | |
| K151325 | Bovie J-Plasma Handpiece | GEI | Substantially Equivalent | |
| K142975 | Bovie Ultimate High Frequency Electrosurgical Generator | GEI | Substantially Equivalent | |
| K134054 | BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | |
| K121441 | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) | HQP | Substantially Equivalent | |
| K112233 | BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE | GEI | Substantially Equivalent | |
| K092149 | BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 | GEI | Substantially Equivalent | |
| K092383 | BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 | GEI | Substantially Equivalent | |
| K093025 | BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES | GEI | Substantially Equivalent | |
| K091440 | LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L | GEI | Substantially Equivalent | |
| K090586 | BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) | GEI | Substantially Equivalent | |
| K082568 | SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE | GEI | Substantially Equivalent | |
| K082109 | BOVIE ICON GENERAL PURPOSE RF GENERATOR | GEI | Substantially Equivalent | |
| K081431 | MEG LAPAROSCOPIC ELECTRODES | GEI | Substantially Equivalent | |
| K072041 | BOVIE IDS-400 ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | |
| K062337 | MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR | GEI | Substantially Equivalent | |
| K061884 | BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 | GEI | Substantially Equivalent | |
| K061307 | BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK | GEI | Substantially Equivalent | |
| K060117 | BOVIE BUTTON REMOTE HAND SWITCH | GEI | Substantially Equivalent | |
| K022856 | BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | |
| K021817 | AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V | GEI | Substantially Equivalent | |
| K020579 | AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 | GEI | Substantially Equivalent | |
| K014201 | AARON REUSABLE ELECTROSURGICAL ELECTRODE | GEI | Substantially Equivalent | |
| K001955 | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 | GEI | Substantially Equivalent | |
| K001382 | AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | GEI | Substantially Equivalent | |
| K000961 | AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE | GEI | Substantially Equivalent | |
| K984352 | AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR | GEI | Substantially Equivalent | |
| K984239 | SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07Z | GEI | Substantially Equivalent | |
| K984236 | AARON ESU FOOT-CONTROL ADAPTER #A1205A | GEI | Substantially Equivalent | |
| K983761 | AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 | GEI | Substantially Equivalent | |
| K983788 | AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE | GEI | Substantially Equivalent | |
| K981570 | AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD | GEI | Substantially Equivalent | |
| K981614 | NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL | GEI | Substantially Equivalent | |
| K974735 | STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE | JOS | Substantially Equivalent | |
| K980366 | AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240 | GEI | Substantially Equivalent | |
| K971621 | RESISTICK SOLID LAPAROSCOPIC ELECTRODES | KNF | Substantially Equivalent | |
| K971805 | ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007593903 | 3007593903 | Apyx Medical Corporation | 5115 Ulmerton Rd, Clearwater, FL 33760 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GFEBrush, Dermabrasion, Powered
- GECBrush, Scrub, Operating-Room
- HOGBurr, Corneal, Battery-Powered
- KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- HGIElectrocautery, Gynecologic (And Accessories)
- JOSElectrode, Electrosurgical
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered
- FSQLight, Surgical, Instrument
- FPASet, Administration, Intravascular
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- ETNStimulator, Nerve
- QPBSystem, Suction, Lipoplasty For Removal
- HQPUnit, Cautery, Thermal, Battery-Powered
- GEHUnit, Cryosurgical, Accessories
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1155-2021 | ConMed 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. | Class II | Open, Classified | |
| Z-1154-2021 | HNM 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. | Class II | Open, Classified | |
| Z-1153-2021 | 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. | Class II | Open, Classified | |
| Z-2061-2020 | Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures. | Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use. | Class II | Terminated | |
| Z-2060-2020 | 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 ablation of soft tissue during open surgical procedures. | Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use. | Class II | Terminated | |
| Z-0198-2019 | 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 surgical procedures. | 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. | Class II | Terminated | |
| Z-1157-2018 | J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF | 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. | Class II | Terminated | |
| Z-1156-2018 | J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR | 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. | Class II | Terminated | |
| Z-1155-2018 | J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B | 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. | Class II | Terminated | |
| Z-1154-2018 | J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N | 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. | Class II | Terminated | |
| Z-1153-2018 | 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. | Class II | Terminated | |
| Z-2649-2016 | BVX-450NR Bovie Precise 360 Handpiece 45cm, needle 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. | Class II | Terminated | |
| Z-2648-2016 | BVX-450BR Bovie Precise 360 Handpiece 45cm, 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. | Class II | Terminated | |
| Z-2647-2016 | BVX-330NR Bovie Precise 360 Handpiece 33cm, needle 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. | Class II | Terminated | |
| Z-2646-2016 | 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. | Class II | Terminated | |
| Z-1239-04 | Battery-operated Cautery High Temperature, fine/Loop/ Vasectomy Tip | The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation. | Terminated | ||
| Z-1238-04 | Battery-operated Cautery Low Temperature, fine/elongated Tip | The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Apyx Medical Corporation edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain