NKY

Blade, Keratome, Reprocessed

Product code

NKY

Device name

Blade, Keratome, Reprocessed

Device class

Class 1

21 CFR

21 CFR 886.4370

Medical specialty

Ophthalmic

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification definition

Blade for keratome to make flap in cornea for LASIK refractive surgery. Same as previously cleared blade for keratomes, product codes HMY and HNO, except this is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).