# K213225: Diode Laser System GP900A8, Diode Laser System GP900Q8

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Gsd Tech Co., Ltd.
- Decided: Dec 22, 2021 after 84 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.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142186: Diode Laser Hair Removal System, Shenzhen Gsd Tech Co., Ltd. (2015) Summary page 4.

## Indications for use
The Diode Laser System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent hair reduction in hair regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent hair reduction in hair regrowth. The Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I-V1), including tanned skin. The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K213225
Methodology: https://510kreport.com/methodology