# K212978: Diode laser therapy system

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Unt Technology Co., Ltd.
- Decided: Nov 10, 2021 after 54 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: 16 generations back to K910422 (1992). 64 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210168: Diode Laser Therapy Systems, Beijing Kes Biology Technology Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K260307: Diode Laser Therapy Systems (V19) (2026), 0 descendants of its own

## Indications for use
The Diode laser therapy system 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/K212978
Methodology: https://510kreport.com/methodology