FDA Registration
Active
🇺🇸 United States
Iridex Cyclo G6 laser system
Reg #: 3002736133
·
FEI: 3002736133
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SPARQTRON CORP.
- Registration Number
- 3002736133
- FEI Number
- 3002736133
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5079 BRANDIN CT.
- City
- FREMONT
- State
- CA
- ZIP
- 94538
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143154
Owner / Operator
- Firm Name
- SPARQTRON CORP.
- Operator Number
- 9065236
- Address
- 5079 BRANDIN CT., --
- City
- Fremont
- State
- CA
- Postal Code
- 94538
- Country
- US
- Correspondent
- Larry - Quach
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2018-05-03 |
Proprietary Names
Iridex Cyclo G6 laser system
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)