# K162755: Picocare

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Jun 12, 2017 after 255 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: 19 generations back to K943450 (1995). 257 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140727: Cutera Picosecond Laser System, Cutera, Inc. (2014) Summary page 5.

## Most influential descendants
- K181272: Picocare Family (2018), 8 descendants of its own
- 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

## Indications for use
The Picocare is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm The 1064 nm wavelength of the Picocare 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). 532 nm The 532 nm wavelength of the Picocare 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/K162755
Methodology: https://510kreport.com/methodology