NLA

Knife, Ophthalmic, Reprocessed

Product code

NLA

Device name

Knife, Ophthalmic, Reprocessed

Device class

Class 1

21 CFR

21 CFR 886.4350

Medical specialty

Ophthalmic

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).