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FDA 510(k)

NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON

K-Number: K001326 · 2000-06-13

ApplicantOcular Concepts, LLC
Decision Date2000-06-13
Product CodeNCK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Ocular Concepts, LLC. It received FDA 510(k) clearance on 2000-06-13 under 510(k) number K001326. The device is classified under product code NCK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON?

NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON is a medical device that received FDA 510(k) clearance on 2000-06-13. The listed applicant is Ocular Concepts, LLC. The 510(k) number is K001326.

When did NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON receive FDA 510(k) clearance?

NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON received FDA 510(k) clearance on 2000-06-13, under 510(k) number K001326.

Who is the listed applicant for NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON?

The FDA 510(k) record lists Ocular Concepts, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON?

The FDA product code for NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON is NCK.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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