# K252447: Picosecond laser device (BMPS4)

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Newangie Technology Co., Ltd.
- Decided: Oct 1, 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: 28 generations back to K943450 (1995). 317 ancestors in all.
No later device cites it as a predicate yet.
0 of 318 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 6.

## 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/K252447
Methodology: https://510kreport.com/methodology