# Blade, Keratome, Reprocessed
> **Product code: 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).

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NKY)
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