NKY — Blade, Keratome, Reprocessed Class I
FDA product code NKY covers "Blade, Keratome, Reprocessed", a Class I medical device regulated under 21 CFR 886.4370. Submissions are reviewed by the Ophthalmic panel.
Classification Details
- Product Code
- NKY
- Device Class
- Class I
- Regulation Number
- 886.4370
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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).