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FDA 510(k)

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

K-Number: K173958 · 2018-04-03

ApplicantVisco Vision, Inc.
Decision Date2018-04-03
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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 is the device name listed in this FDA 510(k) record. The listed applicant is Visco Vision, Inc.. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K173958. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Visco Vision, Inc.. The 510(k) number is K173958.

When did 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 receive FDA 510(k) clearance?

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 received FDA 510(k) clearance on 2018-04-03, under 510(k) number K173958.

Who is the listed applicant for 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?

The FDA 510(k) record lists Visco Vision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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?

The FDA product code for 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 is LPL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06873048Short-term Study of Two Soft Contact Lenses in Wearers With Low AstigmatismCOMPLETEDNCT053259311-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for PresbyopiaCOMPLETEDNCT060537361-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact LensesCOMPLETEDNCT06778057Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact LensesCOMPLETEDNCT06869044A Clinical Comparison of Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal 3 AddCOMPLETEDNCT06995781Evaluation of the Safety and Efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3)COMPLETED

Other records listing Visco Vision, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200618HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact LensK201080Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact LensK191397OxySoft (olifilcon C) silicone hydrogel soft contact lensK183670Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact LensK181349Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact LensK180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lens

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Related Devices (Code: LPL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact LensesPegavision CorporationK261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision CorporationK253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSESGEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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