Clearance Summary
NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON received FDA 510(k) clearance under submission number K001326, sponsored by Ocular Concepts, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-06-13.
- Submission: K001326
- Applicant / Sponsor: Ocular Concepts, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.3200
- Decision date: 2000-06-13
Classification & Regulation
This clearance is catalogued under FDA product code NCK and 21 CFR 886.3200, within the Ophthalmic review panel as a Class I device.