# K201773: Picohi

- Pathway: 510(k) (Traditional)
- Applicant: Hironic Co., Ltd.
- Decided: Oct 19, 2021 after 477 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: 26 generations back to K943450 (1995). 287 ancestors in all.
5 later devices descend from it; 3 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)
- K191685: PicoWay Laser System, Candela Corporation (2019) Summary page 4.

## Most influential descendants
- K234104: PICOANDY (Q-Switched Nd:YAG Laser) (2024), 2 descendants of its own
- K253342: PICO-K (2025), 1 descendant of its own
- K241144: Picosecond Nd:YAG Laser (PICOCAREMAJESTY) (2024), 1 descendant of its own
- K261214: Pico Shining (Pico-K; Picofy) (2026), 0 descendants of its own
- K260017: Picosecond Nd:YAG Laser Systems (Model: HS-298) (2026), 0 descendants of its own

## Indications for use
The PICOHI is indicated for the following at the specified wavelength: * 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. * 532nm: Removal of tattoos for Fitzpatrick skin types I-11I to treat the following tattoo colors: red, yellow and orange. * Treatment of benign pigmented lesions on Fitzpatrick skin types [-IV.

Source page: https://510kreport.com/device/K201773
Methodology: https://510kreport.com/methodology