# K133364: Picosure Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Jul 22, 2014 after 263 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.
51 later devices descend from it; 5 cite it directly.
0 of 304 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 3.
- K103118: Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor, Hoya Photonics, Inc. (2010) Summary page 3.

## Most influential descendants
- K140719: Picosure Workstation (2014), 50 descendants of its own
- 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

## Indications for use
The PicoSure™ workstation is indicated for tattoo and benign pigmented lesion removal. The PicoSure™ workstation operating with the 3mm or 6mm handpiee and the FOCUS lens array is indicated for the treatment of acne scars in Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K133364
Methodology: https://510kreport.com/methodology