# K233007: Picosecond Nd:YAG Laser System; PICO LEGEND

- Pathway: 510(k) (Traditional)
- Applicant: Ami, Inc.
- Decided: Jun 12, 2024 after 264 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.
1 later device descends from it; 1 cites it directly.
0 of 291 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 5.

## Most influential descendants
- K252345: Picosecond Laser Device (PF131-BI) (2025), 0 descendants of its own

## Indications for use
The PICO LEGEND Nd:YAG Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. -The 1064nm wavelength of the PICO LEGEND Nd:YAG Laser 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). -The 532nm wavelength of the PICO LEGEND Nd:YAG Laser 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/K233007
Methodology: https://510kreport.com/methodology