Cleared Traditional

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954) - FDA 510(k) Clearance

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

K222954 · Innova Vision, Inc. · Ophthalmic device
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Mar 2023
Decision
167d
Days
Class 2
Risk

K222954 is an FDA 510(k) clearance for the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Innova Vision, Inc. (Hsinchu, TW). The FDA issued a Cleared decision on March 13, 2023 after a review of 167 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 Innova Vision, Inc. devices

Submission Details

510(k) Number K222954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2022
Decision Date March 13, 2023
Days to Decision 167 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 110d · This submission: 167d
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 K222954.
IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
K230824 · Art Optical Contact Lens, Inc. · Sep 2023
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K222885 · Pegavision Corporation · May 2023
Precision1, Precision1 for Astigmatism
K230785 · Alcon Laboratories, Inc. · Apr 2023
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K220613 · Bausch & Lomb, Incorporated · Mar 2023
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
K221517 · INTEROJO, Inc. · Oct 2022
AIR OPTIX COLORS
K222500 · Alcon Laboratories, Inc. · Sep 2022