FDA 510(k)

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses

K-Number: K212631 · 2022-03-17

Decision Date2022-03-17

Product CodeHQD

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Contamac, Ltd.. It received FDA 510(k) clearance on 2022-03-17 under 510(k) number K212631. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses?

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses is a medical device that received FDA 510(k) clearance on 2022-03-17. The listed applicant is Contamac, Ltd.. The 510(k) number is K212631.

When did Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses receive FDA 510(k) clearance?

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses received FDA 510(k) clearance on 2022-03-17, under 510(k) number K212631.

Who is the listed applicant for Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses?

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

What is the FDA product code for Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses?

The FDA product code for Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses is HQD.

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.

NCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETED NCT06749496Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of WearCOMPLETED NCT07303920Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear DayRECRUITING NCT06751225Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With AstigmatismCOMPLETED NCT06878118The A.R.R.E.S.T.® Contact Lens StudyACTIVE_NOT_RECRUITING NCT07494799Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens WearNOT_YET_RECRUITING

Other records listing Contamac, Ltd. as applicant

PMA P240045Lens, contact, orthokeratology, overnight K182304Hyper GP (tisilfocon A) Daily Wear Contact Lens K181566Nutrifill K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens K171575ENFLU 18 (enflufocon A) Daily Wear Contact Lens K171077HEXA100 (hexafocon A) Daily Wear Contact Lenses

View all 9 devices →

Related Devices (Code: HQD)

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

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.