# K143105: Picosure Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Feb 23, 2015 after 117 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: 20 generations back to K943450 (1995). 274 ancestors in all.
49 later devices descend from it; 5 cite it directly.
0 of 324 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140719: Picosure Workstation, Cynosure, Inc. (2014) Summary page 4.
- K133254: Revlite Q-Switched ND:Yag Laser System, Cynosure, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K191685: PicoWay Laser System (2019), 20 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 3mm 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.

Source page: https://510kreport.com/device/K143105
Methodology: https://510kreport.com/methodology