# K261473: Chromix

- Pathway: 510(k) (Traditional)
- Applicant: Termosalud S.L.
- Decided: Jul 1, 2026 after 58 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: 16 generations back to K943450 (1995). 124 ancestors in all.
No later device cites it as a predicate yet.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212771: LightStim Elipsa, Led Intellectual Properties, LLC (2022) Summary page 5.

## Indications for use
The Chromix is an LED light therapy device which uses specific wavelengths of light, produced by light emitting diodes (LEDs). It is intended to emit energy in the red and infrared region of the light spectrum to provide treatment for full face wrinkles. The blue and red light spectrum is intended for the treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K261473
Methodology: https://510kreport.com/methodology