# K261570: Picosure Workstation

- Pathway: 510(k) (Special)
- Applicant: Cynosure, LLC
- Decided: Jun 17, 2026 after 36 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: 24 generations back to K943450 (1995). 278 ancestors in all.
No later device cites it as a predicate yet.
0 of 279 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210226: PicoSure Workstation, Cynosure, LLC (2021) Summary page 5.

## 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 I – IV. 532nm: The PicoSure 532-nm delivery system is indicated for tattoo removal and benign pigmented lesions removal in Skin Types I-III. 1064nm: The PicoSure 1064-nm delivery system is indicated for tattoo and benign pigmented lesions removal.

Source page: https://510kreport.com/device/K261570
Methodology: https://510kreport.com/methodology