# K252786: Led Light Phototherapy Bed (Pro 450/ GY-680A)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Suyzeko Limited.
- Decided: Dec 1, 2025 after 90 days
- Product code: OLI (Fat Reducing Low Level Laser)
- Device class: 2
- Regulation: 21 CFR 878.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 175 ancestors in all.
No later device cites it as a predicate yet.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202955: Contour Light CL-100, Contour Research, LLC (2021) Summary page 6.
- K153399: LightStim Professional LED Bed, Led Intellectual Properties, LLC (2016) Summary page 5.

## Indications for use
Led Light Phototherapy Bed is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. Led Light Phototherapy Bed is indicated to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, and pain and stiffness associated with arthritis, for promoting relaxation of the muscle tissue, and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K252786
Methodology: https://510kreport.com/methodology