# K234104: PICOANDY (Q-Switched Nd:YAG Laser)

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Mar 15, 2024 after 80 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: 27 generations back to K943450 (1995). 288 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K201773: Picohi, Hironic Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K241144: Picosecond Nd:YAG Laser (PICOCAREMAJESTY) (2024), 1 descendant of its own
- K260017: Picosecond Nd:YAG Laser Systems (Model: HS-298) (2026), 0 descendants of its own

## Indications for use
The PICOANDY is indicated for the following at the specified wavelength: • 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. • 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. • Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K234104
Methodology: https://510kreport.com/methodology