FDA Registration
Active
🇺🇸 United States
OptiLite
Reg #: 2938889
·
FEI: 2938889
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- XINTEC CORPORATION
- Registration Number
- 2938889
- FEI Number
- 2938889
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1660 SOUTH LOOP ROAD
- City
- ALAMEDA
- State
- CA
- ZIP
- 94502
- Country
- US
Regulatory Submissions
- 510(k) Number
- K951910
Owner / Operator
- Firm Name
- XINTEC CORPORATION DBA CONVERGENT LASER TECHNOLOGIES
- Operator Number
- 2938889
- Address
- 1660 SOUTH LOOP ROAD, --
- City
- Alameda
- State
- CA
- Postal Code
- 94502
- Country
- US
- Correspondent
- MARILYN M CHOU, PH.D.
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2008-04-03 |
Proprietary Names
OptiLite
Odyssey
Establishment Types
Manufacture Medical Device