# K253829: Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)

- Pathway: 510(k) (Traditional)
- Applicant: Beijing HuaCheng Taike Technology Co., Ltd.
- Decided: Feb 27, 2026 after 88 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: 24 generations back to K943450 (1995). 289 ancestors in all.
No later device cites it as a predicate yet.
0 of 290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212127: Picocaremajesty, Wontech Co., Ltd. (2022) Summary page 6.

## Indications for use
The Medical Ultra-Pico Laser Treatment System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm The 1064 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). 532 nm The 532 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

Source page: https://510kreport.com/device/K253829
Methodology: https://510kreport.com/methodology