FDA 510(k)

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

Numéro K : K161100 · 2016-08-10

Date de décision2016-08-10

Code produitHQD

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

Optimum GP with HPT (roflufocon A, B, C, D, and E) 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 2016-08-10 under 510(k) number K161100. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Contamac, Ltd.. The 510(k) number is K161100.

When did Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses receive FDA 510(k) clearance?

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 510(k) number K161100.

Who is the listed applicant for Optimum GP with HPT (roflufocon A, B, C, D, and E) 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 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.

Essais cliniques associés

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Autres dossiers indiquant Contamac, Ltd. en tant que demandeur

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Dispositifs connexes (Code : HQD)

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) et Acuity 181™ (tisilfocon A) avec Tangible™ Hydra-PEG® Lentille de Contact Rigid à Perte GazeuseAcuity 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) Lentille de Contact Rigid à Pénétration Gazeuse; Acuity 100™ (hexafocon A) Lentille de Contact Rigid à Pénétration Gazeuse; Acuity 200™ avec Tangible® Hydra-PEG® (fluoroxyfocon A) Lentille de Contact Rigid à Pénétration Gazeuse; Acuity 100™ avec Tangible® Hydra-PEG® (hexafocon A) Lentille de Contact Rigid à Pénétration GazeuseAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

Source officielle

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