# K212127: Picocaremajesty

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Jan 7, 2022 after 184 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: 23 generations back to K943450 (1995). 288 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 295 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181272: Picocare Family, Wontech Co., Ltd. (2018) Summary page 5.
- K200166: Mirus Ligating Clip, Mirus Ligating Clip Applier, M/s. Meril Endo Surgery Private Limited. (2020) Summary page 5.

## Most influential descendants
- K233018: PICOSECOND Nd:YAG Laser System (2023), 2 descendants of its own
- K233007: Picosecond Nd:YAG Laser System; PICO LEGEND (2024), 1 descendant of its own
- K253829: Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) (2026), 0 descendants of its own
- K252345: Picosecond Laser Device (PF131-BI) (2025), 0 descendants of its own
- K240474: Multi-function Platform Systems   (BL-M10) (2024), 0 descendants of its own

## Indications for use
The PICOCAREMAIJESTY Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064nm The 1064nm wavelength of the PICOCAREMAJESTY 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) 532nm The 532nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-I1I

Source page: https://510kreport.com/device/K212127
Methodology: https://510kreport.com/methodology