SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT
FDA premarket approval P910061/S011 · decided 2004-06-14
Approval details
- PMA number
- P910061
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 2004-03-18
- Decision date
- 2004-06-14
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE USE OF A 100% ETHYLENE OXIDE STERILIZATION METHOD IN PRODUCTS IN THEIR FINAL PACKAGED FORM. STERILIZATION WILL OCCUR AT COSMED, INC., LOCATED IN SOUTH PLAINFIELD NEW JERSEY. THE PRODUCTS AFFECTED BY THIS CHANGE ARE THE PMMA AND SILICONE LENSES AND OCUCOAT VISCOADHERENT MANUFACTURED AT BAUSCH & LOMB, INC., CLEARWATER, FLORIDA.
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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 |