# K241547: Diode Laser Therapy Device (DF-DIODE LASER-S1)

- Pathway: 510(k) (Traditional)
- Applicant: Weifang Dragonfly Electronics Technology Co., Ltd.
- Decided: Aug 13, 2024 after 74 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: 15 generations back to K910422 (1992). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211335: Diode Laser Machine, Model Number: BM-100, Zhengzhou Bestview ST Co., Ltd. (2021) Summary page 6.

## Indications for use
The Diode Laser Therapy Device (Model: DF-DIODE LASER-S1) 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/K241547
Methodology: https://510kreport.com/methodology