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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: DuraSoft® 3; DuraSoft® 3 ColorBlends®; DuraSoft® 3 Colors; DuraSoft® 3 Complements®; DuraSoft® 3 LiteTint®; DuraSoft® 3 OptiFit® Toric; DuraSoft® 3 OptiFit® Toric ColorBlends®; DuraSoft® 3 OptiFit® Toric Colors; DuraSoft® 3 OptiFit® Toric Complements®; DuraSoft® 3 OptiFit® Toric LiteTint®; DuraSoft® 3 UV; DuraSoft® 3 UV Colors; DuraSoft® 3 UV Complements®; DuraSoft® 3 UV Handling Tint; DuraSoft® 3 UV OptiFit® Toric; DuraSoft® 3 UV OptiFit® Toric Colors; DuraSoft® 3 UV OptiFit® Toric Complements®; DuraSoft® 3 UV OptiFit® Toric Handling Tint; FreshLook ColorBlends®; FreshLook Dimensions®; FreshLook Radiance¿; FreshLook Toric ColorBlends®; FreshLook®; FreshLook® Color Enhancers; FreshLook® Colors; FreshLook® Handling Tint; FreshLook® Progressive Bifocal Handling Tint; FreshLook® Toric; FreshLook® Toric Colors; FreshLook® Toric Colors Enhancers; FreshLook® Toric Handling Tint; Wild Eyes®; WildEyes® 2 Go
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: 1422160
Owner/Operator: ALCON LABORATORIES, INC.
Owner/Operator Number: 1030321
Establishment Operations: Manufacturer
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