IOLAB BRAND MODEL U85J UVBLOC PLUS (LC) UV-ABSORBING ONE-PIECE FLEXIBLE AC IOLS
FDA premarket approval P870013/S013 · decided 1999-05-13
Approval details
- PMA number
- P870013
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IOLAB BRAND MODEL U85J UVBLOC PLUS (LC) UV-ABSORBING ONE-PIECE FLEXIBLE AC IOLS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 1999-02-17
- Decision date
- 1999-05-13
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., 21 Park Place Blvd., North, Clearwater, FL 33759.
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| STELLARIS VISION ENHANCEMENT SYSTEM (K133242) | Bausch & Lomb | 2014-02-14 |
| BAUSCH & LOMB INJECTOR SYSTEM (K131958) | Bausch & Lomb | 2014-01-09 |
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| CRYSTALSERT DELIVERY SYSTEM (K132593) | Bausch & Lomb | 2013-09-17 |