CLARIS(TM) REWETTING DROPS
FDA premarket approval P900047/S005 · decided 1996-06-20
Approval details
- PMA number
- P900047
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CLARIS(TM) REWETTING DROPS
- Generic name
- Accessories, soft lens products
- Applicant
- Advanced Medical Optics, Inc.
- Date received
- 1996-03-01
- Decision date
- 1996-06-20
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO 1)DUPLICATE WET-N-SOAK REWETTING DROPS UNDER THE TRADE NAME CLARIS REWETTING DROPS TO BE USED WITH CLARIS CLEANING AND SOAKING SOLUTION (ALLERGAN'S TRADE NAME FOR DESTAT 4 CLEANING, DISINFECTING, STORAGE SOLUTION (P870023)) AND 2)ADD THE FOLLOWING TO THE DIRECTIONS SECTION FOR CLARIS REWETTING DROPS: BEFORE WEARING LENSES: PLACE 1 OR 2 DROPS OF CLARIS REWETTING DROPS ON EACH SIDE OF EACH LENS BEFORE APPLICATION
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VITRECTOMY CUTTER AND ACCESSORIES (K081681) | Advanced Medical Optics, Inc. | 2008-10-08 |
| ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 (K081545) | Advanced Medical Optics, Inc. | 2008-10-02 |
| THE AMO OPHTHALMIC SURGICAL SYSTEM (K060366) | Advanced Medical Optics, Inc. | 2006-04-07 |
| LENS PLUS REWETTING DROPS (K042562) | Advanced Medical Optics, Inc. | 2005-07-29 |
| SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK (K050648) | Advanced Medical Optics, Inc. | 2005-04-05 |
| COMPLETE BLINK-N-CLEAN LENS DROPS (K040839) | Advanced Medical Optics, Inc. | 2004-10-19 |
| BLINK CL LUBRICANT EYE DROPS (K032030) | Advanced Medical Optics, Inc. | 2003-09-25 |
| COMPLETE BRAND MULTI-PURPOSE SOLUTION (K030092) | Advanced Medical Optics, Inc. | 2003-04-04 |