# K200525: Medical Diode Laser Hair Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Weifang Mingliang Electronics Co., Ltd.
- Decided: May 27, 2020 after 86 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: 15 generations back to K910422 (1992). 85 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181019: Diode Laser System, Guangzhou Huafei Tongda Technology Co., Ltd. (2018) Summary page 5.
- K153718: Spirit Hair Removal laser Family, Active Optical Systems, Ltd. (2016) Summary page 5.

## Most influential descendants
- K241860: Diode Laser Hair Removal System (2024), 0 descendants of its own

## Indications for use
The Medical Diode Laser Hair Removal System is used for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types ( Fitzpatrick I-VI), including tanned skin.

Source page: https://510kreport.com/device/K200525
Methodology: https://510kreport.com/methodology