# K251329: Diode laser device (RF3120-BI)

- Pathway: 510(k) (Traditional)
- Applicant: Risu Medical Technology Co., Ltd.
- Decided: Jun 27, 2025 after 58 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: 25 generations back to K943450 (1995). 566 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 569 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222064: The Alma Soprano Titanium, Alma Lasers, Inc. (2022) Summary page 5.

## Most influential descendants
- K261817: Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) (2026), 0 descendants of its own
- K252599: Diode Laser Therapy Systems (WLA-02) (2026), 0 descendants of its own

## Indications for use
The Diode laser device is intended for use in dermatology procedures requiring coagulation.The indications for use for the Trio-Wavelength Handpiece include: The Fast Hair Removal (FHR) Mode is intended for temporary hair reduction.The HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions. The 810nm wavelength handpiece is intended 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. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and FHR Modes).

Source page: https://510kreport.com/device/K251329
Methodology: https://510kreport.com/methodology