SOFLEX POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P910061/S014 · decided 2008-08-28
Approval details
- PMA number
- P910061
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOFLEX POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 2006-04-03
- Decision date
- 2008-08-28
- Days to decision
- 878 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR USE OF THE EASY LOAD LENS RETAINER FOR PACKAGING THE LI61AO LENS.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |