A373000
A373000 is a Class II device made by Ophthalmed LLC, cleared under FDA 510(k) K021696 on 20 Aug 2002 and listed in FDA GUDID since 9 Feb 2018 (UDI-DI M735A3730001), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM735A3730001 | Date9 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021696 | Date20 Aug 2002 | StatusActive |
Official records
- FDA 510(k) database K021696
Across registries
- FDA 510(k) K021696 decided 20 Aug 2002 Active
- FDA GUDID UDI-DI M735A3730001 listed 9 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K021696
- Listed FDA GUDID M735A3730001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Ophthalmic laser system beam guide
- Model / reference
- A373000
- Primary DI / UDI-DI
- M735A3730001
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Ophthalmic laser system beam guide
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 25 Gauge
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