FDA Registration
Active
🇺🇸 United States
Apyx Medical Corporation
Reg #: 3007593903
·
FEI: 3007593903
·
Expires 2026
Products
6
Proprietary Names
48
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- Apyx Medical Corporation
- Registration Number
- 3007593903
- FEI Number
- 3007593903
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5115 Ulmerton Rd
- City
- Clearwater
- State
- FL
- ZIP
- 33760
- Country
- US
Regulatory Submissions
- 510(k) Number
- K253396
Owner / Operator
- Firm Name
- Apyx Medical Corporation
- Operator Number
- 9910100
- Address
- 5115 ULMERTON ROAD, --
- City
- Clearwater
- State
- FL
- Postal Code
- 33760
- Country
- US
- Correspondent
- Scott Goldstein
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2026-05-11 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-06-21 |
| Unit, Cautery, Thermal, Battery-Powered | HQP | Class 2 | Ophthalmic | No | 2007-10-05 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2023-04-13 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2007-11-19 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2007-11-19 |
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
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
AYON Body Contouring System
Apyx Disposable Split Electrode
J-Plasma Precise FLEX
Apyx One Console
Apyx One Console Helium Gas Regulator, Digital
High Temperature Cautery Elongated Fine Tip
High Temperature Cautery 5 Loop
APYX-1253B Monopolar Footswitch
Renuvion APR Handpiece
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
APYX-1254B Bipolar Footswitch
IDS-210
IDS-310
A2350
A3350
APYX-330BPS - J-Plasma Precise Blade Tip, 5mm, 33cm-length a.k.a:BVX-330BPS-J-Plasma Precice Blade Tip, 5mm, 33cm-length
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility