Cleared Traditional

Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

K161739 · Pegavision Corporation · Ophthalmic
Dec 2016
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K161739 is an FDA 510(k) clearance for the Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Pegavision Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on December 19, 2016, 178 days after receiving the submission on June 24, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K161739 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2016
Decision Date December 19, 2016
Days to Decision 178 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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