FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/
FDA premarket approval P830037/S045 · decided 2002-05-01
Approval details
- PMA number
- P830037
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2002-03-28
- Decision date
- 2002-05-01
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A CHANGE OF TINT FROM PHTHALOCYANINE GREEN TO CARBAZOLE VIOLET FOR FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) UV SOFT (HYDROPHILIC) CONTACT LENSES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATION: FRESHLOOK SPHERICAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY
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