FDA Registration
Active
🇺🇸 United States
NEAUVIA NORTH AMERICA, INC
Reg #: 3015433394
·
FEI: 3015433394
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- NEAUVIA NORTH AMERICA, INC
- Registration Number
- 3015433394
- FEI Number
- 3015433394
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8480 Honeycutt Rd
- City
- Raleigh
- State
- NC
- ZIP
- 27615
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223222
Owner / Operator
- Firm Name
- Neauvia North America
- Operator Number
- 10061623
- Address
- 8480 Honeycutt Rd
- City
- Raleigh
- State
- NC
- Postal Code
- 27615
- Country
- US
- Correspondent
- Joy Willard
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-03-20 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-06-09 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2019-11-04 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2021-09-24 |
Proprietary Names
Plasma IQ
EpilMe
ALIYA
LaserMe
Zaffiro
Sectum
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility