NLA — Knife, Ophthalmic, Reprocessed Class I
FDA product code NLA covers "Knife, Ophthalmic, Reprocessed", a Class I medical device regulated under 21 CFR 886.4350. Submissions are reviewed by the Ophthalmic panel.
Classification Details
- Product Code
- NLA
- Device Class
- Class I
- Regulation Number
- 886.4350
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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).