# K231896: Diode Laser Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Adss Development Co., Ltd.
- Decided: Feb 20, 2024 after 237 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: 26 generations back to K943450 (1995). 572 ancestors in all.
No later device cites it as a predicate yet.
0 of 573 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230371: The Alma Soprano Titanium, Alma Lasers, Inc. (2023) Summary page 5.
- K220381: Diode Laser Therapy Systems, Beijing Lasertell Medical Co., Ltd. (2022) Summary page 5.

## Indications for use
The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction. The Diode Laser Therapy System(Model: FG2000-D+/FG2000-D+Pro/FG2000-E) 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/K231896
Methodology: https://510kreport.com/methodology