Fsa 38
Fsa 38 is a Class II device made by Paragon Vision Sciences, cleared under FDA 510(k) K984436 on 21 Apr 1999 and listed in FDA GUDID since 16 Mar 2018 (UDI-DI B22211), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | NumberB22211 | Date16 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK984436 | Date21 Apr 1999 | StatusActive |
Official records
- FDA 510(k) database K984436
Across registries
- FDA 510(k) K984436 decided 21 Apr 1999 Active
- FDA GUDID UDI-DI B22211 listed 16 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K984436
- Listed FDA GUDID B22211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
- Model / reference
- FSA 38
- Primary DI / UDI-DI
- B22211
- FDA product code
- HQD
- GMDN term
- Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
- Device class
- Class II
- Regulation number
- 886.5916
- GUDID distribution status
- Not in Commercial Distribution
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