Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004878380

FEI Number

3004878380

Entity Name

Apyx Bulgaria Ltd.

City/State/Country

Sofia, BG

Establishment Address

Boul. Tsarigradsko shose, 133, BIC IZOT, Building 3, floors 1, 2, 3, 4 and 5, Sofia 1784, BG

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Apyx Medical Corporation (Owner Number: 10034275)

Owner / Operator Contact Address

5115 Ulmerton Road, --, Clearwater, FL 33760, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Renuvion System Generator J-Plasma System Generator Apyx Sterile Brush Apyx One Console Aaron 1250 High Frequency Electrosurgical Generator APYX-1253B Monopolar Footswitch Renuvion/J-Plasma Precise Handpiece and Precise Open Handpiece ESU-1 Electrosurgical Generator Bovie Medical Aaron 900 High Frequency Dessiccator/Handpiece APYX-1254B Bipolar Footswitch Bovie Medical AYON Body Contouring System Renuvion/J-Plasma Precise Handpiece Footswitch Double Pedal J-Plasma Bovie Ultimate Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator Bovie J-Plasma Precise Open Handpiece Bovie ULTIMATE High Frequency Electrosurgical Generator Apyx Plasma-RF Handpiece

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-01-03
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	2022-10-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-03-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-07-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-12-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-07-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-11-18
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	2023-07-18
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	2016-03-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-07-18

Official Correspondent

Scott Goldstein

US Agent Details

Scott Goldstein Business: Apyx Medical Corporation Email: Scott.Goldstein@apyxmedical.com Phone: (727) 8038517

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
3007593903	Apyx Medical Corporation	Clearwater, FL, US

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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3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004878380. Last updated year: 2026. Please use registration number 3004878380 when referencing this establishment in official correspondence.