# K222685: NIRA Model 2

- Pathway: 510(k) (Traditional)
- Applicant: Dermal Photonics Corp
- Decided: Feb 8, 2023 after 155 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K910422 (1992). 172 ancestors in all.
No later device cites it as a predicate yet.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163137: NIRA Beauty Skin Laser, Dermal Photonics Corporation (2017) Summary page 4.

## Indications for use
The NIRA Model 2 is indicated for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K222685
Methodology: https://510kreport.com/methodology