FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS)
FDA premarket approval P850079/S040 · decided 2002-06-13
Approval details
- PMA number
- P850079
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2002-05-15
- Decision date
- 2002-06-13
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR EXTENDED WEAR APPROVAL FOR THE FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES WITH UV ABSORBING MONOMER. THESE DEVICES, PREVIOUSLY CLEARED FOR DAILY WEAR UNDER K020392, WILL BE MARKETED UNDER THE TRADE NAMES LISTED BELOW FOR THE FOLLOWING INDICATIONS FOR USE:FREQUENCY 55 UV AND FREQUENCY 55 UV ASPHERIC LENSES ARE INDICATED FOR DAILY WEAR AND EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. T
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