# K180353: Diode laser hair removal device

- Pathway: 510(k) (Traditional)
- Applicant: Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Decided: Apr 17, 2018 after 68 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.
24 later devices descend from it; 7 cite 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)
- K162659: Diode Laser Hair Removal System, Shandong Huamei Technology Co., Ltd. (2017) Summary page 7.

## Most influential descendants
- K210663: Dermatological Diode Laser Systems (2021), 8 descendants of its own
- K221312: Diode Laser Hair Removal Device (2022), 4 descendants of its own
- K210168: Diode Laser Therapy Systems (2021), 4 descendants of its own
- K202980: Laser Therapy Device (2020), 2 descendants of its own
- K192735: Diode Laser Hair Removal Machine (2020), 2 descendants of its own

## Indications for use
The Diode Laser Hair Removal device 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/K180353
Methodology: https://510kreport.com/methodology