# K252603: HIGHERDOSE Body Sculptor (Model: GS-03)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Jan 28, 2026 after 163 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). 155 ancestors in all.
No later device cites it as a predicate yet.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223893: Infrared Heat (Model: E0221), Light Tree Ventures Europe B.V. (2023) Summary page 6.
- K250532: Solawave 2-in-1 Skincare Mini (Model: 61043), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2025) Summary page 6.
- K242789: Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006), Dongguan Laiguang Electronic Technology Co., Ltd. (2025) Summary page 6.

## Indications for use
The HIGHERDOSE BODY SCULPTOR (Model: GS-03) is an over-the-counter device that is intended to improve the appearance of wrinkles.

Source page: https://510kreport.com/device/K252603
Methodology: https://510kreport.com/methodology