# K183392: PicoLO Nd:YAG Picosecond Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Laseroptek Co., Ltd.
- Decided: Jan 4, 2019 after 28 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: 25 generations back to K943450 (1995). 286 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170597: PicoWay Laser System, Syneron Candela Corporation (2017) Summary page 4.

## Most influential descendants
- K203491: PicoLO Nd: YAG Picosecond Laser System (2021), 1 descendant of its own
- K212573: PicoLO Premium (2021), 0 descendants of its own

## Indications for use
PicoLO 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 PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. 532nm The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

Source page: https://510kreport.com/device/K183392
Methodology: https://510kreport.com/methodology