Cleared Special

K220070 - MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens

K220070 is an FDA 510(k) clearance for MyDay (stenfilcon A) Soft (Hydrophilic)..., manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Special 510(k) pathway after a 25-day FDA review.

K220070 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
25d
Days
Class 2
Risk

K220070 is an FDA 510(k) clearance for the MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by CooperVision, Inc. (San Ramon, US). The FDA issued a Cleared decision on February 4, 2022 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K220070

510(k) Number K220070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2022
Decision Date February 04, 2022
Days to Decision 25 days
Submission Type Special
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
85d faster than avg
Panel avg: 110d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 489
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K220070.
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
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
K213119 · Innova Vision, Inc. · May 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
Alcon (serafilcon A) soft contact lenses for daily wear
K212806 · Alcon Laboratories, Inc. · Dec 2021
K220070 · MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
Download PDF FDA Summary CooperVision, Inc.