FRESHLOOK UV (PHEMFILCON A) SPHERICAL SOFT CONTACT LENSES FOR EXTENDED WEAR
FDA premarket approval P830037/S053 · decided 2012-02-07
Approval details
- PMA number
- P830037
- Supplement
- S053
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRESHLOOK UV (PHEMFILCON A) SPHERICAL SOFT CONTACT LENSES FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2011-09-23
- Decision date
- 2012-02-07
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE USE THE NEW PHOENIX VT PRINT PADS USED TO TRANSFER INKS ONTO THE LENS SURFACE AND FOR THE ADDITION OF A PRE-CONDITIONING STEP FOR OPTIMAL INK ADHESION ONTO THE LENSES WHEN THE NEW PRINT PAD IS UTILIZED.
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