Product code NKY

Device name

Blade, Keratome, Reprocessed

Medical specialty

Ophthalmic

Device class

1

Regulation number

886.4370

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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).

Source

FDA openFDA device classification dataset