# K221312: Diode Laser Hair Removal Device

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Chuang Zao Mei Technology Co., Ltd.
- Decided: Jun 29, 2022 after 55 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: 16 generations back to K910422 (1992). 64 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210663: Dermatological Diode Laser Systems, Beijing HuaCheng Taike Technology Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K250431: Medical Diode Laser Hair Removal System (MNLT-D1) (2025), 1 descendant of its own
- K252048: 808nm semiconductor laser hair removal machine (2026), 0 descendants of its own
- K243465: Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) (2025), 0 descendants of its own
- K241498: Diode laser Treatment System (K18) (2024), 0 descendants of its own

## Indications for use
The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) 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/K221312
Methodology: https://510kreport.com/methodology