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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 the device name listed in this FDA 510(k) record. The listed applicant is Contamac, Ltd.. It received FDA 510(k) clearance on 2016-07-13 under 510(k) 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. The listed applicant is Contamac, Ltd.. The 510(k) number is K160859.

When did OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) receive FDA 510(k) clearance?

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

Who is the listed applicant for OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)?

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 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 records listing Contamac, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P240045Lens, contact, orthokeratology, overnightK212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesK182304Hyper GP (tisilfocon A) Daily Wear Contact LensK181566NutrifillK180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact LensK171575ENFLU 18 (enflufocon A) Daily Wear Contact Lens

View all 9 devices →

Related Devices (Code: MUW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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