Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions
FDA has developed this guidance document to assist industry in preparing premarket notification submissions for keratomes and replacement keratome blades. The device is intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant. Keratomes, originally used during cornea transplant surgery, are now widely used during the laser refractive surgical procedure known as laser-assisted in situ keratomileusis (LASIK).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.