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FDA 510(k)

OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

K-Number: K160859 · 2016-07-13

ApplicantContamac, Ltd.
Decision Date2016-07-13
Product CodeMUW
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is a medical device manufactured by Contamac, Ltd.. It received FDA 510(k) clearance on 2016-07-13 under approval number K160859. The device is classified under product code MUW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)?

OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is a medical device that received FDA 510(k) clearance on 2016-07-13. It is manufactured by Contamac, Ltd.. The 510(k) number is K160859.

When was OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) approved by the FDA?

OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) received FDA 510(k) clearance on 2016-07-13, under approval number K160859.

What company makes OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)?

OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is manufactured by Contamac, Ltd..

What is the FDA product code for OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)?

The FDA product code for OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is MUW.

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 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

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Related Devices (Code: MUW)

K183200iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact LensesC&E GP Specialist, Inc.

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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