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FDA 510(k)

Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

K-Number: K153766 · 2016-04-08

ApplicantINTEROJO, Inc.
Decision Date2016-04-08
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is a medical device manufactured by INTEROJO, Inc.. It received FDA 510(k) clearance on 2016-04-08 under approval number K153766. 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 Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear?

Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by INTEROJO, Inc.. The 510(k) number is K153766.

When was Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear approved by the FDA?

Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear received FDA 510(k) clearance on 2016-04-08, under approval number K153766.

What company makes Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear?

Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by INTEROJO, Inc..

What is the FDA product code for Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear?

The FDA product code for Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is LPL.

Related Clinical Trials

NCT07588659 Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD) NOT_YET_RECRUITING NCT06749496 Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear COMPLETED NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes COMPLETED NCT07076160 Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses COMPLETED NCT07223086 Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity RECRUITING NCT06778057 Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses COMPLETED

Other Devices by INTEROJO, Inc.

K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) 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.

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