FDA 510(k)

59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS

K-Number: K040303 · 2005-02-02

Decision Date2005-02-02

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Hydrogel Vision Corporation. It received FDA 510(k) clearance on 2005-02-02 under 510(k) number K040303. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS?

59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS is a medical device that received FDA 510(k) clearance on 2005-02-02. The listed applicant is Hydrogel Vision Corporation. The 510(k) number is K040303.

When did 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS receive FDA 510(k) clearance?

59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS received FDA 510(k) clearance on 2005-02-02, under 510(k) number K040303.

Who is the listed applicant for 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS?

The FDA 510(k) record lists Hydrogel Vision Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS?

The FDA product code for 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS is LPL.

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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.