# K131838: Diode Laser for Hiar Removal

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Honkon Technologies Co., Ltd.
- Decided: Apr 24, 2014 after 308 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: 11 generations back to K910422 (1992). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application, Alma Lasers, Inc. (2011) Summary page 1.

## Indications for use
The diode laser for hair removal is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type 1-VI). 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/K131838
Methodology: https://510kreport.com/methodology