# K251076: Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Lifotronic Technology Co., Ltd.
- Decided: Jul 30, 2025 after 113 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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.
No later device cites it as a predicate yet.
0 of 316 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.

## 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/K251076
Methodology: https://510kreport.com/methodology