# K252345: Picosecond Laser Device (PF131-BI)

- Pathway: 510(k) (Traditional)
- Applicant: Risu Medical Technology Co., Ltd.
- Decided: Oct 23, 2025 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: 29 generations back to K943450 (1995). 325 ancestors in all.
No later device cites it as a predicate yet.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200116: PicoSecond Nd: YAG Laser System, Shanghai Apolo Medical Technology Co., Ltd. (2020) Summary page 5.
- K191685: PicoWay Laser System, Candela Corporation (2019) Summary page 5.
- K233007: Picosecond Nd:YAG Laser System; PICO LEGEND, Ami, Inc. (2024) Summary page 5.
- K220268: Picosecond Laser System (Model PS10-A and PS10-B), Beijing Adss Development Co., Ltd. (2022) Summary page 5.

## Indications for use
The Picosecond Laser device is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: - Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. 532nm wavelength: - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K252345
Methodology: https://510kreport.com/methodology