IPAFLUOROFOCON A AND B
FDA premarket approval P860022/S050 · decided 1998-03-31
Approval details
- PMA number
- P860022
- Supplement
- S050
- Supplement type
- THIRTY DAY TRACK
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IPAFLUOROFOCON A AND B
- Generic name
- Lens, contact (other material) - daily
- Applicant
- Bausch & Lomb
- Date received
- 1998-02-20
- Decision date
- 1998-03-31
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval for the three additional finishing laboratories listed to become additional manufacturers and distributors of the device:Premier Contact Lens, 111 28th Avenue South, Nashville, TN 37212 and Premier Contact Lens, 3614 S.Perkins, Memphis, TN 38118.
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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 |