CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SOFT CONTACT LENSES
FDA premarket approval P010019/S021 · decided 2011-09-09
Approval details
- PMA number
- P010019
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2011-03-01
- Decision date
- 2011-09-09
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A TRADE NAME CHANGE TO THE (LOTRAFILCON B) SOFT CONTACT LENSES WITH WETTING AGENT IN PACKAGE SALINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) AND IS INDICATED FOR THE FOLLOWING: CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SPHERICAL SOFT CONTACT LENSES ARE INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WITH UP TO APPROXIMATELY 1.50 D
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510(k) clearances by this applicant
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