# K153527: PicoWay Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Candela Corporation
- Decided: Mar 2, 2016 after 84 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: 21 generations back to K943450 (1995). 282 ancestors in all.
41 later devices descend from it; 5 cite it directly.
0 of 324 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150326: PicoWay Laser System, Candela Corporation (2015) Summary page 4.
- K142372: Pico Way Laser System, Candela Corpation (2014) Summary page 4.
- K143105: Picosure Workstation, Cynosure, Inc. (2015) Summary page 4.
- K140719: Picosure Workstation, Cynosure, Inc. (2014) Summary page 4.
- K133364: Picosure Workstation, Cynosure, Inc. (2014) Summary page 4.
- K121346: Picosure Workstation, Cynosure, Inc. (2012) Summary page 4.
- K140727: Cutera Picosecond Laser System, Cutera, Inc. (2014) Summary page 4.

## Most influential descendants
- K160607: PicoWay Laser System (2016), 34 descendants of its own
- K162454: PicoWay Laser System (2017), 33 descendants of its own
- K170597: PicoWay Laser System (2017), 32 descendants of its own
- K191685: PicoWay Laser System (2019), 20 descendants of its own
- K172077: Cutera enlighten III Laser System (2017), 9 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. The PicoWay Laser System is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

Source page: https://510kreport.com/device/K153527
Methodology: https://510kreport.com/methodology