Cleared Traditional

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

K211603 · Pegavision Corporation · Ophthalmic
Feb 2022
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K211603 is an FDA 510(k) clearance for the Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) 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 February 2, 2022, 254 days after receiving the submission on May 24, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K211603 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2021
Decision Date February 02, 2022
Days to Decision 254 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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