FDA 510(k), K173958, OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
FDA 510(k), K173958, OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
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510(K) Number: K173958
Device Name: OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
Manufacturer: Visco Vision Inc
Device Classification Name: lenses, soft contact, daily wear
Regulation Number: 886.5925
Classification Product Code: LPL
Date Received: 12/28/2017
Decision Date: 04/03/2018
Regulation Medical Specialty: Ophthalmic
Device Name: OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
Manufacturer: Visco Vision Inc
Device Classification Name: lenses, soft contact, daily wear
Regulation Number: 886.5925
Classification Product Code: LPL
Date Received: 12/28/2017
Decision Date: 04/03/2018
Regulation Medical Specialty: Ophthalmic
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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