Custom Stable Optimum Exra (roflufocon D) Light Blue
Custom Stable Optimum Exra (roflufocon D) Light Blue is a Class II device made by Valley Contax, Inc., cleared under FDA 510(k) K213880 on 7 Jan 2022 and listed in FDA GUDID since 8 Apr 2024 (UDI-DI 00860011844105), active as of 22 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 | Number00860011844105 | Date8 Apr 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213880 | Date7 Jan 2022 | StatusActive |
Official records
- AccessGUDID record 00860011844105
- FDA 510(k) database K213880
Across registries
- FDA 510(k) K213880 decided 7 Jan 2022 Active
- FDA GUDID UDI-DI 00860011844105 listed 8 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K213880
- Listed FDA GUDID 00860011844105
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Custom Stable
- Generic name
- Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
- Model / reference
- Optimum Exra (roflufocon D) Light Blue
- Primary DI / UDI-DI
- 00860011844105
- 510(k) Number
- 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
- In Commercial Distribution
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