Cleared Traditional

AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES

K120028 · Pegavision Corporation · Ophthalmic
Apr 2012
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K120028 is an FDA 510(k) clearance for the AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Pegavision Corporation (Taoyuan, TW). The FDA issued a Cleared decision on April 17, 2012, 104 days after receiving the submission on January 4, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K120028 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2012
Decision Date April 17, 2012
Days to Decision 104 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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