FDA 510(k)

AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES

K-Number: K120028 · 2012-04-17

Decision Date2012-04-17

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Pegavision Corporation. It received FDA 510(k) clearance on 2012-04-17 under 510(k) number K120028. 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 AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES?

AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES is a medical device that received FDA 510(k) clearance on 2012-04-17. The listed applicant is Pegavision Corporation. The 510(k) number is K120028.

When did AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES receive FDA 510(k) clearance?

AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES received FDA 510(k) clearance on 2012-04-17, under 510(k) number K120028.

Who is the listed applicant for AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES?

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

What is the FDA product code for AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES?

The FDA product code for AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES 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.