# K162659: Diode Laser Hair Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Huamei Technology Co., Ltd.
- Decided: Jun 16, 2017 after 263 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: 13 generations back to K910422 (1992). 61 ancestors in all.
40 later devices descend from it; 9 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141973: Diode Laser Hair Removal System, Beijing Anchorfree Technology Co., Ltd. (2014) Summary page 7.
- K123483: Diode Laser, Beijing Syntech Laser CO., LTD. (2013) Summary page 7.

## Most influential descendants
- K180353: Diode laser hair removal device (2018), 24 descendants of its own
- K210663: Dermatological Diode Laser Systems (2021), 8 descendants of its own
- K181019: Diode Laser System (2018), 6 descendants of its own
- K211335: Diode Laser Machine, Model Number: BM-100 (2021), 5 descendants of its own
- K221312: Diode Laser Hair Removal Device (2022), 4 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/K162659
Methodology: https://510kreport.com/methodology