Cleared Traditional

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) (K210930) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210930 · Johnson & Johnson Vision Care, Inc. · Ophthalmic device
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Nov 2021
Decision
245d
Days
Class 2
Risk

K210930 is an FDA 510(k) clearance for the ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A). Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Johnson & Johnson Vision Care, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 29, 2021 after a review of 245 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 Johnson & Johnson Vision Care, Inc. devices

Submission Details

510(k) Number K210930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2021
Decision Date November 29, 2021
Days to Decision 245 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
135d slower than avg
Panel avg: 110d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 99
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K210930.
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
Avaira Vitality
K213164 · CooperVision, Inc. · Oct 2021
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K210975 · Bausch & Lomb, Incorporated · May 2021
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
K210609 · Vp Optics · Apr 2021