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FDA product code NKY

Blade, Keratome, Reprocessed

OphthalmicClass 121 CFR 886.4370
Verified
US regulatory classifications
US Product Code (FDA)
NKY
View Product Code Classification
US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 886.4370
View CFR Regulation
Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
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).

Search keywords

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01Keratome blade02Reprocessed blade03Ophthalmic blade04Eye surgery05Surgical blade06Microkeratome07Reusable blade08Vision surgery09Corneal blade10Blade reprocessed
About this record

Blade, Keratome, Reprocessed is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.