# K212478: Dermatological diode laser system

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Stelle Laser Technology Co., Ltd.
- Decided: Jan 14, 2022 after 158 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: 14 generations back to K910422 (1992). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162659: Diode Laser Hair Removal System, Shandong Huamei Technology Co., Ltd. (2017) Summary page 7.

## Indications for use
The Dermatological diode laser 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/K212478
Methodology: https://510kreport.com/methodology