# K140719: Picosure Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Sep 22, 2014 after 185 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: 19 generations back to K943450 (1995). 254 ancestors in all.
50 later devices descend from it; 5 cite it directly.
0 of 305 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.
- K133364: Picosure Workstation, Cynosure, Inc. (2014). Cleared while this submission was under review Summary page 4.
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 4.

## Most influential descendants
- K143105: Picosure Workstation (2015), 49 descendants of its own
- K153527: PicoWay Laser System (2016), 41 descendants of its own
- 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

## Indications for use
The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure™ workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.

Source page: https://510kreport.com/device/K140719
Methodology: https://510kreport.com/methodology