FDA Registration
Active
🇺🇸 United States
A4xx010 (20g laser/asp probe)
Reg #: 3004497289
·
FEI: 3004497289
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OPHTHALMED LLC
- Registration Number
- 3004497289
- FEI Number
- 3004497289
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1050 Northfield Ct Ste 280
- City
- ROSWELL
- State
- GA
- ZIP
- 30076
- Country
- US
Regulatory Submissions
- 510(k) Number
- K050807
Owner / Operator
- Firm Name
- OPHTHALMED LLC
- Operator Number
- 9051325
- Address
- 1050 NORTHFIELD COURT, SUITE 280
- City
- Roswell
- State
- GA
- Postal Code
- 30076
- Country
- US
- Correspondent
- JAY - MANSOUR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2005-12-23 |
Proprietary Names
A4xx010 (20g laser/asp probe)
A5xxx0x (20g, 23g and 25g laser/illum probe)
A92x013 (23g laser/asp probe)
A6xxx10 (20g laser/illum/asp probe)
B62xx13 (23g laser/illum/asp probe)
Establishment Types
Manufacture Medical Device