Cleared Traditional

K223074 - CorNeat EverPatch (FDA 510(k) Clearance)

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

K223074 · Corneat Vision , Ltd. · Ophthalmic device
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Jun 2023
Decision
245d
Days
Class 2
Risk

K223074 is an FDA 510(k) clearance for the CorNeat EverPatch. Classified as Prosthesis, Eyelid Spacer/graft, Polymer (product code QWU), Class II - Special Controls.

Submitted by Corneat Vision , Ltd. (Raanana, IL). The FDA issued a Cleared decision on June 2, 2023 after a review of 245 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3130 - 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 Corneat Vision , Ltd. devices

Submission Details

510(k) Number K223074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2022
Decision Date June 02, 2023
Days to Decision 245 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
135d slower than avg
Panel avg: 110d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QWU Prosthesis, Eyelid Spacer/graft, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3130
Definition For Implantation To Reinforce And Aid In Reconstruction Of The Soft Tissues Of The Eyelid And Eyelid Area.
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.