Cleared Traditional

AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES

K140025 · Pegavision Corporation · Ophthalmic
Oct 2014
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K140025 is an FDA 510(k) clearance for the AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) 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 October 15, 2014, 282 days after receiving the submission on January 6, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K140025 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 2014
Decision Date October 15, 2014
Days to Decision 282 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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