# K181019: Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Huafei Tongda Technology Co., Ltd.
- Decided: Jul 16, 2018 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: 14 generations back to K910422 (1992). 84 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 91 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.
- K142845: SILKPRO laser hair removal system, Wuhan Lotuxs Technology Co., Ltd. (2015) Summary page 7.
- 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 7.
- K153718: Spirit Hair Removal laser Family, Active Optical Systems, Ltd. (2016) Summary page 7.

## Most influential descendants
- K200525: Medical Diode Laser Hair Removal System (2020), 1 descendant of its own
- K192569: Diode Laser Therapy System (2019), 1 descendant of its own
- K192516: Diode Laser 808nm (2019), 1 descendant of its own
- K241860: Diode Laser Hair Removal System (2024), 0 descendants of its own
- K202257: Dermatological Diode Laser Systems (2021), 0 descendants of its own

## Indications for use
The 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/K181019
Methodology: https://510kreport.com/methodology