# K163137: NIRA Beauty Skin Laser

- Pathway: 510(k) (Traditional)
- Applicant: Dermal Photonics Corporation
- Decided: Jul 12, 2017 after 245 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: 13 generations back to K910422 (1992). 171 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090525: Loi System, Palomar Medical Products, Inc. (2009) Summary page 4.

## Most influential descendants
- K222685: NIRA Model 2 (2023), 0 descendants of its own

## Indications for use
The NIRA Beauty Skin Laser is indicated for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K163137
Methodology: https://510kreport.com/methodology