PICOSURE WORKSTATION— 510(k) K261570
Substantially EquivalentCynosure, LLC
FDA 510(k) clearance K261570 for PICOSURE WORKSTATION, Substantially Equivalent on 2026-06-17. Applicant: Cynosure, LLC. Device class: 2.
Summary
Cynosure's PICOSURE WORKSTATION is filed under GEX, powered laser surgical instruments. The record doesn't describe the workstation beyond its name and the code name.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Special 510(k).
Cynosure filed from Wesford, Massachusetts, as the record spells the town. The decision came 36 calendar days after receipt (May 12 to June 17, 2026).
Clearance details
- Applicant
- Cynosure, LLC
- Product code
- Product code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Wesford, MA, US
Recent devices under product code GEX
view allMore clearances from Cynosure, LLC
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.