FDA 510(k)

OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES

K-Number: K081178 · 2008-10-09

Decision Date2008-10-09

Product CodeHQD

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) 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 2008-10-09 under 510(k) number K081178. 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 OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES?

OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Contamac, Ltd.. The 510(k) number is K081178.

When did OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES receive FDA 510(k) clearance?

OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES received FDA 510(k) clearance on 2008-10-09, under 510(k) number K081178.

Who is the listed applicant for OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) 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 HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES?

The FDA product code for OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES is HQD.

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Related Devices (Code: HQD)

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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.