# K241144: Picosecond Nd:YAG Laser (PICOCAREMAJESTY)

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Jun 24, 2024 after 60 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: 28 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)
- K234104: PICOANDY (Q-Switched Nd:YAG Laser), Wontech Co., Ltd. (2024) Summary page 6.
- K201773: Picohi, Hironic Co., Ltd. (2021) Summary page 6.

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

## Indications for use
The PICOCAREMAJESTY 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 - Ill to treat the following tattoo colors: red, yellow and orange. * Treatment of benign pigmented lesions for Fitzpatrick skin types 1-IV.

Source page: https://510kreport.com/device/K241144
Methodology: https://510kreport.com/methodology