FDA Registration
Active
🇮🇱 Israel
OptiLight IPL Handpiece
Reg #: 3009040934
·
FEI: 3009040934
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ATENA (FROM THE IMCO GROUP) LTD
- Registration Number
- 3009040934
- FEI Number
- 3009040934
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HaTa'asiya 9
- City
- Nesher Haifa
- Country
- IL
Regulatory Submissions
- 510(k) Number
- DEN200028
Owner / Operator
- Firm Name
- ATENA (FROM THE IMCO GROUP) LTD
- Operator Number
- 10091388
- Address
- HaTa'asiya 9
- City
- Nesher
- State
- Haifa
- Postal Code
- 3688808
- Country
- IL
- Correspondent
- Roei Oring
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intense Pulsed Light Device For Managing Dry Eye | QIU | Class 2 | Ophthalmic | No | 2024-09-15 |
Proprietary Names
OptiLight IPL Handpiece
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)