FDA Registration
Active
🇺🇸 United States
Bovie J-Plasma Handpiece
Reg #: 3007593903
·
FEI: 3007593903
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Apyx Medical Corporation
- Registration Number
- 3007593903
- FEI Number
- 3007593903
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5115 Ulmerton Rd
- City
- Clearwater
- State
- FL
- ZIP
- 33760
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151325
Owner / Operator
- Firm Name
- Apyx Medical Corporation
- Operator Number
- 9910100
- Address
- 5115 ULMERTON ROAD, --
- City
- Clearwater
- State
- FL
- Postal Code
- 33760
- Country
- US
- Correspondent
- Angela Huber
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2015-10-15 |
Proprietary Names
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
Establishment Types
Manufacture Medical Device