FDA 510(k)

OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL

K-Number: K241707 · 2024-07-12

Decision Date2024-07-12

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL is a medical device manufactured by Unicon Optical Co., Ltd.. It received FDA 510(k) clearance on 2024-07-12 under approval number K241707. 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 OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL?

OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by Unicon Optical Co., Ltd.. The 510(k) number is K241707.

When was OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL approved by the FDA?

OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL received FDA 510(k) clearance on 2024-07-12, under approval number K241707.

What company makes OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL?

OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL is manufactured by Unicon Optical Co., Ltd..

What is the FDA product code for OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL?

The FDA product code for OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL is LPL.

Related Clinical Trials

NCT06864858 Clinical Evaluation of Two Cosmetic Contact Lenses COMPLETED NCT07588659 Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD) NOT_YET_RECRUITING NCT07566234 Evaluation of Contact Lenses and Myopia. NOT_YET_RECRUITING NCT07600645 Contact Lens Trial Fitting Experience NOT_YET_RECRUITING NCT06749496 Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear COMPLETED NCT07586982 Clinical Performance of Verofilcon A Toric Contact Lenses RECRUITING

Other Devices by Unicon Optical Co., Ltd.

K191929UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens

Related Devices (Code: LPL)

K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. K160245Visco (olifilcon A) soft contact lensVisco Vision, Inc. K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd. K162596AIR OPTIX COLORSAlcon Laboratories, Inc. K161931Toricolors (hioxifilcon D) Soft Contact LensesPolydev , Ltd.

Official Source

View on FDA Database →

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