# K121346: Picosure Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Nov 27, 2012 after 207 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: 17 generations back to K943450 (1995). 251 ancestors in all.
87 later devices descend from it; 12 cite it directly.
0 of 339 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992814: Cynosure Accolade Laser, Cynosure, Inc. (1999) Summary page 5.
- K103118: Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor, Hoya Photonics, Inc. (2010) Summary page 5.

## Most influential descendants
- K142372: Pico Way Laser System (2014), 70 descendants of its own
- K150326: PicoWay Laser System (2015), 68 descendants of its own
- K133364: Picosure Workstation (2014), 51 descendants of its own
- K140719: Picosure Workstation (2014), 50 descendants of its own
- K143105: Picosure Workstation (2015), 49 descendants of its own

## Indications for use
The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal.

Source page: https://510kreport.com/device/K121346
Methodology: https://510kreport.com/methodology