Cleared Traditional

K211603 - Aquamax (Etafilcon A) Daily Disposable ...

K211603 is an FDA 510(k) clearance for Aquamax (Etafilcon A) Daily Disposable ..., manufactured by Pegavision Corporation. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 254-day FDA review.

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

K211603 is an FDA 510(k) clearance for the Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aqu.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Pegavision Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on February 2, 2022 after a review of 254 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Pegavision Corporation devices

FDA 510(k) Submission Details - K211603

510(k) Number K211603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 110d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 164
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K211603.
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K220045 · Dk Medivision Co., Ltd. · Aug 2022
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
K213119 · Innova Vision, Inc. · May 2022
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
K220070 · CooperVision, Inc. · Feb 2022
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
K213216 · Unicon Optical Co., Ltd. · Jan 2022
Alcon (serafilcon A) soft contact lenses for daily wear
K212806 · Alcon Laboratories, Inc. · Dec 2021
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
K211448 · Pegavision Corporation · Dec 2021