Cleared Traditional

KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT (K090078) - FDA 510(k) Clearance

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

K090078 · Iop, Inc. · Ophthalmic device
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May 2009
Decision
116d
Days
Class 2
Risk

K090078 is an FDA 510(k) clearance for the KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT. Classified as Prosthesis, Eyelid Spacer/graft, Biologic (product code NXM), Class II - Special Controls.

Submitted by Iop, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on May 8, 2009 after a review of 116 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K090078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2009
Decision Date May 08, 2009
Days to Decision 116 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 110d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXM Prosthesis, Eyelid Spacer/graft, Biologic
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.
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.