IPAFLUOROFOCON A AND B
FDA premarket approval P860022/S048 · decided 1997-10-15
Approval details
- PMA number
- P860022
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- IPAFLUOROFOCON A AND B
- Generic name
- Lens, contact (other material) - daily
- Applicant
- Bausch & Lomb
- Date received
- 1997-09-16
- Decision date
- 1997-10-15
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval for the five additional finishing laboratories listed in the enclosure to become additional manufacturers and distributors of the contact lenses. FDA also acknowledges your notification of a new adopted USAN name for EQUALENS II (oprifocon A).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Stellaris Elite vision enhancement system (K170052) | Bausch+Lomb | 2017-04-19 |
| Stellaris Elite Vision Enhancement System (K162342) | Bausch+Lomb | 2017-03-24 |
| STELLARIS PC VISION ENHANCEMENT SYSTEM (K133486) | Bausch & Lomb | 2014-03-12 |
| STELLARIS VISION ENHANCEMENT SYSTEM (K133242) | Bausch & Lomb | 2014-02-14 |
| BAUSCH & LOMB INJECTOR SYSTEM (K131958) | Bausch & Lomb | 2014-01-09 |
| BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (K133146) | Bausch & Lomb | 2014-01-03 |
| EASY-LOAD LENS DELIVERY SYSTEM (K132481) | Bausch & Lomb | 2013-12-27 |
| CRYSTALSERT DELIVERY SYSTEM (K132593) | Bausch & Lomb | 2013-09-17 |