# K240386: Picosecond Nd:YAG Laser Systems (BL-C10)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Bele Medical Technology Co.,Ltd
- Decided: May 16, 2024 after 98 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: 26 generations back to K943450 (1995). 294 ancestors in all.
No later device cites it as a predicate yet.
0 of 295 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233018: PICOSECOND Nd:YAG Laser System, Ids, Ltd. (2023) Summary page 5.
- K191685: PicoWay Laser System, Candela Corporation (2019) Summary page 5.

## Indications for use
The Picosecond Nd: YAG Laser System 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-Ill 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/K240386
Methodology: https://510kreport.com/methodology