# K220103: LED Therapy Device (Planar LED/Planar LED mini)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Leaflife Technology Co., Ltd.
- Decided: Apr 12, 2022 after 90 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: 19 generations back to K950019 (1995). 101 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202980: Laser Therapy Device, Shenzhen Leaflife Technology Co., Ltd. (2020) Summary page 5.
- K120737: Tria Laser Hair Removal System, Tria Beauty, Inc. (2012) Summary page 5.
- K181568: IPL Salon Hair Reduction System, Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt (2018) Summary page 5.

## Most influential descendants
- K230362: Planar LED mate (2023), 0 descendants of its own

## Indications for use
The LED Therapy Device is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K220103
Methodology: https://510kreport.com/methodology