UNIZYME(TM) ENZYMATIC CLEANER
FDA premarket approval P960024/S001 · decided 1997-07-03
Approval details
- PMA number
- P960024
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UNIZYME(TM) ENZYMATIC CLEANER
- Generic name
- Accessories, solution, ultrasonic cleaners for lenses
- Applicant
- Ciba Vision Corporation
- Date received
- 1997-04-15
- Decision date
- 1997-07-03
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LYL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Duluth, GA
- Statement
- Approval for addition of Ciba Vision's SOLOCare(TM) Brand Multi-Purpose Solution to the labeling of the Unizyme(TM) Enzymatic Cleaner as a diluent to be used sequentially with the Unizyme(TM) enzyme.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL (K133176) | Ciba Vision Corporation | 2014-01-29 |
| DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL (K123994) | Ciba Vision Corporation | 2013-02-21 |
| DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC (K113168) | Ciba Vision Corporation | 2012-03-30 |
| CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (K083216) | Ciba Vision Corporation | 2009-04-14 |
| CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES (K073459) | Ciba Vision Corporation | 2008-02-28 |
| CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (K072777) | Ciba Vision Corporation | 2008-01-24 |
| CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS (K062262) | Ciba Vision Corporation | 2006-11-14 |
| SOLO-CARE AQUA ANTIMICROBIAL LENS CASE (K041820) | Ciba Vision Corporation | 2005-09-09 |