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FDA 510(k)

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens

K-Number: K152657 · 2016-05-17

ApplicantSmart Performer Corp. , Ltd.
Decision Date2016-05-17
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is a medical device manufactured by Smart Performer Corp. , Ltd.. It received FDA 510(k) clearance on 2016-05-17 under approval number K152657. 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 SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens?

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2016-05-17. It is manufactured by Smart Performer Corp. , Ltd.. The 510(k) number is K152657.

When was SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens approved by the FDA?

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens received FDA 510(k) clearance on 2016-05-17, under approval number K152657.

What company makes SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens?

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is manufactured by Smart Performer Corp. , Ltd..

What is the FDA product code for SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens?

The FDA product code for SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is LPL.

Related Clinical Trials

NCT07559188 Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40884106 Biosensor-embedded wearables for dry eye monitoring and management. Expert review of medical devices (2025)

Other Devices by Smart Performer Corp. , Ltd.

K151847SMART PERFORMER (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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