Cleared Traditional

K213119 - Innova Vision Hydrogel (Hioxifilcon A) ...

K213119 is an FDA 510(k) clearance for Innova Vision Hydrogel (Hioxifilcon A) ..., manufactured by Innova Vision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K213119 · Innova Vision, Inc. · Ophthalmic device
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May 2022
Decision
228d
Days
Class 2
Risk

K213119 is an FDA 510(k) clearance for the Innova Vision Hydrogel (Hioxifilcon 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 May 13, 2022 after a review of 228 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

FDA 510(k) Submission Details - K213119

510(k) Number K213119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date May 13, 2022
Days to Decision 228 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
118d slower than avg
Panel avg: 110d · This submission: 228d
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 K213119.
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
K220143 · Shenzhen Dashicheng Optical Technology Co., Ltd. · Sep 2022
Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
K213983 · Yung Sheng Optical Co., Ltd. · Sep 2022
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K220045 · Dk Medivision Co., Ltd. · Aug 2022
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
K220070 · CooperVision, Inc. · Feb 2022
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
K211603 · Pegavision Corporation · Feb 2022
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
K213216 · Unicon Optical Co., Ltd. · Jan 2022