FDA 510(k)

ENFLU 18 (enflufocon A) Daily Wear Contact Lens

N.º K: K171575 · 2017-10-24

Fecha de decisión2017-10-24

Código de productoHQD

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

ENFLU 18 (enflufocon A) Daily Wear Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Contamac, Ltd.. It received FDA 510(k) clearance on 2017-10-24 under 510(k) number K171575. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ENFLU 18 (enflufocon A) Daily Wear Contact Lens?

ENFLU 18 (enflufocon A) Daily Wear Contact Lens is a medical device that received FDA 510(k) clearance on 2017-10-24. The listed applicant is Contamac, Ltd.. The 510(k) number is K171575.

When did ENFLU 18 (enflufocon A) Daily Wear Contact Lens receive FDA 510(k) clearance?

ENFLU 18 (enflufocon A) Daily Wear Contact Lens received FDA 510(k) clearance on 2017-10-24, under 510(k) number K171575.

Who is the listed applicant for ENFLU 18 (enflufocon A) Daily Wear Contact Lens?

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 ENFLU 18 (enflufocon A) Daily Wear Contact Lens?

The FDA product code for ENFLU 18 (enflufocon A) Daily Wear Contact Lens is HQD.

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Otros registros que enlistan a Contamac, Ltd. como solicitante

K212631Optimum Infinite (tisilfocon 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 K171077HEXA100 (hexafocon A) Daily Wear Contact Lenses K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses

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Dispositivos relacionados (Código: HQD)

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Lentes de Contacto Rígidas Gas Permeables Acuity 181™ (tisilfocon A) y Acuity 181™ (tisilfocon A) con Tangible™ Hydra-PEG®Acuity 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 K240618Lente de Contacto Rígida Gas Permeable Acuity 200™ (fluoroxyfocon A); Lente de Contacto Rígida Gas Permeable Acuity 100™ (hexafocon A); Lente de Contacto Rígida Gas Permeable Acuity 200™ con Tangible® Hydra-PEG® (fluoroxyfocon A); Lente de Contacto Rígida Gas Permeable Acuity 100™ con Tangible® Hydra-PEG® (hexafocon A)Acuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.