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GUIDANCE DOCUMENT

Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions Guidance for Industry and FDA Staff September 2006

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

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

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.