# K250761: KALA Therapy Wand (Model: KALA-03)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Jul 11, 2025 after 120 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: 21 generations back to K943450 (1995). 315 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 317 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241718: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W), Shenzhen Aozemei Technology Co., Ltd. (2024) Summary page 5.
- K161434: Photon Vibrating massage Facial Aesthetic Device (Model: UI-200), Li-Tek Electronics Technologies (2017) 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.

## Most influential descendants
- K252272: ORA Method LED Gua Sha (GS-04) (2025), 0 descendants of its own

## Indications for use
The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K250761
Methodology: https://510kreport.com/methodology