Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007593903

FEI Number

3007593903

Entity Name

Apyx Medical Corporation

City/State/Country

Clearwater, FL, US

Establishment Address

5115 Ulmerton Rd, Clearwater, FL 33760, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Apyx Medical Corporation (Owner Number: 9910100)

Owner / Operator Contact Address

5115 ULMERTON ROAD, --, Clearwater, FL 33760, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151325

PMA Number

N/A

All Registered Proprietary Names

AYON Body Contouring System DERM 942 High Frequency Desiccator Bantam PRO Electrosurgical Generator DERM 941 High Frequency Desiccator J-Plasma Precise FLEX Handpiece APYX-500BF - J-Plasma Precise® FLEX 500mm a.k.a BVX-500BF - J-Plasma Precise® FLEX 500mm Bovie Medical Low Temperature Cautery Elongated Fine Tip APYX-150-BPP Renuvion/J-Plasma Precise Open 150mm a.k.a: BVX-150-BPP Renuvion/J-Plasma Precise Open 150mm APYX-044-BPS Renuvion/J-Plasma Precise Open 44mm a.k.a: BVX-044-BPS Renuvion/J-Plasma Precise Open 44mm APYX-270BPP Renuvion Precise Blade Tip 5mm, 27cm a.k.a: BVX-270BPP Renuvion Precise Blade Tip 5mm, 27cm APYX-270B Renuvion/J-Plasma Precise Blade Tip 5mm, 27cm a.k.a: BVX-270B Renuvion/J-Plasma Precise Blade Tip 5mm, 27cm APYX-150-BPS Renuvion/J-Plasma Precise Open 150mm a.k.a: BVX-150-BPS Renuvion/J-Plasma Precise Open 150mm APYX-150B Renuvion/J-Plasma Precise Blade Tip 5mm, 15cm a.k.a: BVX-150B Renuvion/J-Plasma Precise Blade Tip 5mm, 15cm APYX-330B Renuvion/J-Plasma Precise Blade Tip 5mm, 33cm a.k.a: BVX-330B Renuvion/J-Plasma Precise Blade Tip 5mm, 33cm Bovie Ultimate Electrosurgical Generator APYX-JPDFS Renuvion/J-Plasma Footswitch Dual Pedal a.k.a: BVX-JPDFS Renuvion/J-Plasma Footswitch Dual Pedal APYX-044-BPS Renuvion/J-Plasma Precise Open 44mm, a.k.a BVX-044-BPS Renuvion/J-Plasma Precise Open 44mm APYX-200H - J-Plasma System Generator a.k.a: BVX-200H - J-Plasma System Generator APYX-200P - Renuvion System Generator a.k.a: BVX-200P - Renuvion System Generator Renuvion Micro Handpiece Apyx Sterile Brush Renuvion System Generator J-Plasma System Generator High Temperature Cautery Bovie Medical Renuvion Dermal Handpiece Renuvion Dermal System Bovie Ultimate (BVX-100H) APYX-HGS- Renuvion/J-Plasma Generator Helium Gas Regulator a.k.a:BV-HGS Renuvion/J-Plasma Generator Helium Gas Regulator Servoprax Bovie Medical AYON Body Contouring System High Temperature Cautery Bovie Medical Apyx Disposable Split Electrode J-Plasma Precise FLEX Apyx One Console Apyx One Console Helium Gas Regulator, Digital High Temperature Cautery Elongated Fine Tip Bovie Medical Bovie Medical High Temperature Cautery 5 Loop APYX-1253B Monopolar Footswitch Renuvion APR Handpiece High Temperature Cautery Bovie Medical Bovie J-Plasma Handpiece APYX-150B - Renuvion/J-Plasma Precise Blade Tip, 5mm, 150mm-length a.k.a: BVX-150B - Renuvion/J-Plasma Precice Blade APYX-270B - Renuvion/J-Plasma Precise Blade Tip, 5mm, 27cm-length a.k.a: BVX-270B - Renuvion/J-Plasma Precice Blade

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2026-05-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-05-01
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	Class 2	886.4115	2007-10-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-04-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-03-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-16
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2023-04-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-01-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-10-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-06-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-12-23
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2007-11-19
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2025-05-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-10-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-05-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-10-27
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-09-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-10-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-10-15

Official Correspondent

Scott Goldstein

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Apyx Medical Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004878380	Apyx Bulgaria Ltd.	Sofia, BG

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007593903. Last updated year: 2026. Please use registration number 3007593903 when referencing this establishment in official correspondence.