# K252272: ORA Method LED Gua Sha (GS-04)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Oct 9, 2025 after 79 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: 22 generations back to K943450 (1995). 317 ancestors in all.
No later device cites it as a predicate yet.
0 of 318 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250761: KALA Therapy Wand (Model: KALA-03), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2025) Summary page 5.
- K242382: décoLITE LED Device, iSMART Developments, Ltd. (2024) Summary page 6.
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B), Shenzhen Nuon Medical Equipment Co., Ltd. (2024) Summary page 6.

## Indications for use
The ORA Method LED Gua Sha (Model: GS-04) is an Over-the-Counter (OTC) device indicated to emit energy in red and infrared region of the spectrum for treatment of full-face and decolletage wrinkles.

Source page: https://510kreport.com/device/K252272
Methodology: https://510kreport.com/methodology