FDA 510(k)

ENFLU 18 (enflufocon A) Daily Wear Contact Lens

K-Number: K171575 · 2017-10-24

Decision Date2017-10-24

Product CodeHQD

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Other records listing Contamac, Ltd. as applicant

PMA P240045Lens, contact, orthokeratology, overnight 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

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.