FDA product code NLA: Knife, Ophthalmic, Reprocessed
NLA is the FDA product code for knife, ophthalmic, reprocessed. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. Devices under NLA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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).
Classification
| Field | Value |
|---|---|
| Device name | Knife, Ophthalmic, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NLA devices
openFDA lists no recalls for product code NLA.
Frequently asked questions
What is FDA product code NLA?
NLA is the FDA product code for knife, ophthalmic, reprocessed. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is NLA?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NLA
- Run a recall and safety report across every NLA manufacturer
- Watch product code NLA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.