# K200118: Diode Laser Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: Apr 17, 2020 after 87 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: 24 generations back to K943450 (1995). 565 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 567 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules, Alma Lasers, Inc. (2018) Summary page 4.

## Most influential descendants
- K240474: Multi-function Platform Systems   (BL-M10) (2024), 0 descendants of its own

## Indications for use
The Diode Laser Therapy Device is indicated 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. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Source page: https://510kreport.com/device/K200118
Methodology: https://510kreport.com/methodology