# K233862: Nuna Lux (NUNL528)

- Pathway: 510(k) (Traditional)
- Applicant: Premier North America, Inc.
- Decided: Mar 1, 2024 after 86 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: 4 generations back to K101190 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210823: LYMA Laser, Lyma Life, Ltd. (2022) Summary page 5.

## Indications for use
The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.

Source page: https://510kreport.com/device/K233862
Methodology: https://510kreport.com/methodology