510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001326Substantially Equivalent

Natural-Iris Pre-Pigmented Corneal Button

Ocular Concepts, LLC, Lake Oswego OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001326 is the FDA 510(k) clearance record for NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON, a class I device, cleared for Ocular Concepts, LLC on under FDA product code NCK (Button, Iris, Eye, Artificial). FDA records list one 510(k) clearance for Ocular Concepts, LLC. As of , FDA records show no recalls naming K001326.

Clearance record

Decision date
Received
(48 days to decision)
Product code
NCK Button, Iris, Eye, Artificial
Regulation
21 CFR 886.3200
Device class
Class I
Review panel
Ophthalmic
Applicant
Ocular Concepts, LLC 4035 SW Mercantile Dr., Lake Oswego OR
510(k) summary
Summary
Third party review
No

Clearances, product code NCK

Trailing 12 months

FDA records hold no clearances under product code NCK in the trailing twelve months.

FDA records show no clearances under product code NCK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260