# K142372: Pico Way Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corpation
- Decided: Oct 30, 2014 after 66 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: 18 generations back to K943450 (1995). 252 ancestors in all.
70 later devices descend from it; 7 cite it directly.
0 of 323 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121346: Picosure Workstation, Cynosure, Inc. (2012) Summary page 4.
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 4.

## Most influential descendants
- K150326: PicoWay Laser System (2015), 68 descendants of its own
- K153527: PicoWay Laser System (2016), 41 descendants of its own
- K152012: EVO platform (2015), 37 descendants of its own
- K151473: NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module (2015), 37 descendants of its own
- K160368: EVO platform (2016), 36 descendants of its own

## Indications for use
The PicoWay Laser System is indicated for the following at the specified wavelength: 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow, and orange. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue, and purple.

Source page: https://510kreport.com/device/K142372
Methodology: https://510kreport.com/methodology