Cleared Traditional

K200296 - Pegavision (Etafilcon A) Color Daily Di...

K200296 is the FDA 510(k) clearance for Pegavision (Etafilcon A) Color Daily Di... by Pegavision Corporation. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K200296 · Pegavision Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
252d
Days
Class 2
Risk

K200296 is an FDA 510(k) clearance for the Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Le.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Pegavision Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on October 15, 2020 after a review of 252 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 Pegavision Corporation devices

Submission Details

510(k) Number K200296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2020
Decision Date October 15, 2020
Days to Decision 252 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
142d slower than avg
Panel avg: 110d · This submission: 252d
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 160
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K200296.
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
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 · CooperVision, Inc. · 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
Miru 1day UpSide (midafilcon A)
K193399 · Menicon Co, Ltd. · Jun 2020