NLA · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.4350
Classification
FDA Product Code
NLA
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 886.4350
Review panel
OP
Medical specialty
Ophthalmic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
Used for cutting soft tissue in or around the eye. Surgical knife same as product code HNN, except this one 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).