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FDA 510(k)

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses

K-Number: K212631 · 2022-03-17

ApplicantContamac, Ltd.
Decision Date2022-03-17
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses is a medical device manufactured by Contamac, Ltd.. It received FDA 510(k) clearance on 2022-03-17 under approval 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. It is manufactured by Contamac, Ltd.. The 510(k) number is K212631.

When was Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses approved by the FDA?

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

What company makes Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses?

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses is manufactured by Contamac, Ltd..

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

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Other Devices by Contamac, Ltd.

K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses K160859OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) K171575ENFLU 18 (enflufocon A) Daily Wear Contact Lens K171077HEXA100 (hexafocon A) Daily Wear Contact Lenses K182304Hyper GP (tisilfocon A) Daily Wear Contact Lens K181566Nutrifill

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Related Devices (Code: HQD)

K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. K153714SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear CoSynergeyes, Inc. K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. K160938SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc. K161461BostonSight PD Prosthetic DeviceBostonsight K152724EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSESAdvanced Vision Technologies

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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