NKY · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.4370
Classification
FDA Product Code
NKY
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 886.4370
Review panel
OP
Medical specialty
Ophthalmic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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).