# K181272: Picocare Family

- Pathway: 510(k) (Special)
- Applicant: Wontech Co., Ltd.
- Decided: Jul 31, 2018 after 78 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: 22 generations back to K943450 (1995). 284 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 293 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162755: Picocare, Wontech Co., Ltd. (2017) Summary page 5.
- K153527: PicoWay Laser System, Syneron Candela Corporation (2016) Summary page 5.

## Most influential descendants
- K212127: Picocaremajesty (2022), 6 descendants of its own
- 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

## Indications for use
The Picocare Family 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 Picocare Family 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 Picocare Family 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/K181272
Methodology: https://510kreport.com/methodology