# K210226: PicoSure Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, LLC
- Decided: Mar 30, 2021 after 61 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: 23 generations back to K943450 (1995). 277 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 281 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173199: PicoSure Workstation, Cynosure, Inc. (2018) Summary page 4.

## Most influential descendants
- K261570: Picosure Workstation (2026), 0 descendants of its own
- K252369: Boston Pico755 (2026), 0 descendants of its own
- K243957: Picoalex (2025), 0 descendants of its own

## Indications for use
755nm: The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma. 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 [ - IV. 532nm: The PicoSure 532-nm delivery system is indicated for tattoo removal and benign pigmented lesions removal in Skin Types I-111. 1064nm: The PicoSure 1064-nm delivery system is indicated for tattoo and benign pigmented lesions removal.

Source page: https://510kreport.com/device/K210226
Methodology: https://510kreport.com/methodology