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FDA 510(k)

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses

K-Number: K161100 · 2016-08-10

ApplicantContamac, Ltd.
Decision Date2016-08-10
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses is a medical device manufactured by Contamac, Ltd.. It received FDA 510(k) clearance on 2016-08-10 under approval number K161100. 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 GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses?

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses is a medical device that received FDA 510(k) clearance on 2016-08-10. It is manufactured by Contamac, Ltd.. The 510(k) number is K161100.

When was Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses approved by the FDA?

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses received FDA 510(k) clearance on 2016-08-10, under approval number K161100.

What company makes Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses?

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses is manufactured by Contamac, Ltd..

What is the FDA product code for Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses?

The FDA product code for Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses is HQD.

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 Contamac, Ltd.

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 K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

View all 9 devices →

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. 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 K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight

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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