# K233018: PICOSECOND Nd:YAG Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Ids, Ltd.
- Decided: Dec 21, 2023 after 90 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.
2 later devices descend from it; 2 cite it directly.
0 of 292 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
- K240474: Multi-function Platform Systems   (BL-M10) (2024), 0 descendants of its own
- K240386: Picosecond Nd:YAG Laser Systems (BL-C10) (2024), 0 descendants of its own

## Indications for use
The PICOSECOND Nd:YAG Laser System (PICO PREMIUM) 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 PICOSECOND Nd:YAG Laser System (PICO PREMIUM ) 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 PICOSECOND Nd:YAG Laser System (PICO PREMIUM ) 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/K233018
Methodology: https://510kreport.com/methodology