# K170597: PicoWay Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Candela Corporation
- Decided: May 25, 2017 after 86 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: 24 generations back to K943450 (1995). 285 ancestors in all.
32 later devices descend from it; 6 cite it directly.
0 of 318 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K162454: PicoWay Laser System, Syneron Candela Corporation (2017) Summary page 4.
- K160607: PicoWay Laser System, Syneron Candela Corporation (2016) Summary page 4.
- K153527: PicoWay Laser System, Syneron Candela Corporation (2016) Summary page 4.
- K150326: PicoWay Laser System, Candela Corporation (2015) Summary page 4.
- K142372: Pico Way Laser System, Candela Corpation (2014) Summary page 4.

## Most influential descendants
- K191685: PicoWay Laser System (2019), 20 descendants of its own
- K172077: Cutera enlighten III Laser System (2017), 9 descendants of its own
- K173700: PICOPLUS Laser System (2018), 7 descendants of its own
- K200116: PicoSecond Nd: YAG Laser System (2020), 6 descendants of its own
- K201773: Picohi (2021), 5 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. 785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 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. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The Resolve handpieces are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

Source page: https://510kreport.com/device/K170597
Methodology: https://510kreport.com/methodology