# K160480: PicoSure Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: May 17, 2016 after 85 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). 275 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 296 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.
- K133254: Revlite Q-Switched ND:Yag Laser System, Cynosure, Inc. (2014) Summary page 4.

## Most influential descendants
- K173199: PicoSure Workstation (2018), 9 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
- K210226: PicoSure Workstation (2021), 3 descendants of its own

## Indications for use
755 nm: The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV. 532 nm: The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I - III. 1064 nm: The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.

Source page: https://510kreport.com/device/K160480
Methodology: https://510kreport.com/methodology