# K260688: Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: May 4, 2026 after 62 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: 20 generations back to K943450 (1995). 197 ancestors in all.
No later device cites it as a predicate yet.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241947: EnergyLounger (TY-01), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2025) Summary page 5.
- K232977: Biophotas Celluma CONTOUR, Biophotas, Inc. (2023) Summary page 5.
- K243854: Contour Light (CL-100), Contour Research, LLC (2026) Summary page 5.
- K202955: Contour Light CL-100, Contour Research, LLC (2021) Summary page 5.
- K192544: Erchonia Emerald, Erchonia Corporation (2020) Summary page 5.

## Indications for use
For model HY-150A/HY-150B/HY-200A/HY-200B/HY-420A: M1 is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. M2 and M3 are intended to deliver heat in the Red+IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. For model HY-200D/HY-200C M3 is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m2. M1 and M2 are intended to deliver heat in the Red, IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K260688
Methodology: https://510kreport.com/methodology