Cleared Traditional

AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES

K123973 · Pegavision Corporation · Ophthalmic
Apr 2013
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K123973 is an FDA 510(k) clearance for the AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Pegavision Corporation (Taoyuan, Kwei Shan Hsiang, TW). The FDA issued a Cleared decision on April 23, 2013, 118 days after receiving the submission on December 26, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K123973 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2012
Decision Date April 23, 2013
Days to Decision 118 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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