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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: AIR OPTIX® AQUA; AIR OPTIX® AQUA MULTIFOCAL; AIR OPTIX® for ASTIGMATISM (previously O2OPTIX¿ Toric; O2OPTIX¿ Toric for Astigmatism; O2OPTIX¿ for Astigmatism); AIR OPTIX® NIGHT & DAY® AQUA; NIGHT & DAY® (formerly, Focus NIGHT & DAY® and commercialized in some markets as AIR OPTIX® NIGHT & DAY®); O2OPTIX¿ (Commercialized in some markets as AIR OPTIX®)
Classification Name: LENSES, SOFT CONTACT, EXTENDED WEAR
Product Code: LPM
Device Class: 3
Regulation Number: 886.5925
Medical Specialty: Ophthalmic
Registered Establishment Name: ALCON LABORATORIES, INC.
Registered Establishment Number: 1053053
Owner/Operator: ALCON LABORATORIES, INC.
Owner/Operator Number: 1030321
Establishment Operations: Specification Developer; Complaint File Establishment
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