Cleared Special

K202756 - Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)

K202756 is an FDA 510(k) clearance for Clariti 1 Day (somofilcon A), 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 29-day FDA review.

K202756 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
29d
Days
Class 2
Risk

K202756 is an FDA 510(k) clearance for the Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 D.... 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 October 20, 2020 after a review of 29 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 - K202756

510(k) Number K202756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2020
Decision Date October 20, 2020
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
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 K202756.
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo
K202129 · Largan Medical Co., Ltd. · Apr 2021
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
K200618 · Visco Vision, Inc. · Dec 2020
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K201268 · Plexus Optix, Inc. · Oct 2020
Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses
K200296 · Pegavision Corporation · Oct 2020
Optixon 1-Day
K201013 · Optixon, Inc. · Sep 2020
Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
K201080 · Visco Vision, Inc. · Jul 2020
K202756 · Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
Download PDF FDA Summary CooperVision, Inc.