FDA Registration
Active
🇰🇷 South Korea
Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
Reg #: 3012440264
·
FEI: 3012440264
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- FINEMEC Co., Ltd
- Registration Number
- 3012440264
- FEI Number
- 3012440264
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 604-1, 217, Heojun-Ro
- City
- Gangseo-gu Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K182663
Owner / Operator
- Firm Name
- FineMEC Co., Ltd.
- Operator Number
- 10050037
- Address
- 604-1, 701, 217, Heojun-Ro
- City
- Gangseo-gu
- State
- Seoul
- Postal Code
- 07531
- Country
- KR
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2018-12-17 |
Proprietary Names
Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device