Cleared Traditional

K001326 - NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON

K001326 is an FDA 510(k) clearance for NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON, manufactured by Ocular Concepts, LLC. The device is a Class 1 Ophthalmic device with product code NCK cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K001326 · Ocular Concepts, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
48d
Days
Class 1
Risk

K001326 is an FDA 510(k) clearance for the NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON. Classified as Button, Iris, Eye, Artificial (product code NCK), Class I - General Controls.

Submitted by Ocular Concepts, LLC (Lake Oswego, US). The FDA issued a Cleared decision on June 13, 2000 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ocular Concepts, LLC devices

FDA 510(k) Submission Details - K001326

510(k) Number K001326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2000
Decision Date June 13, 2000
Days to Decision 48 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
62d faster than avg
Panel avg: 110d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

NCK Device Classification - Class 1, General Controls

Product Code NCK Button, Iris, Eye, Artificial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.3200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.