K261570
- 510(k) number
- K261570
- Device name
- PICOSURE WORKSTATION
- Applicant
- Cynosure, LLC MA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-06-17
- Date received
- 2026-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K261570.pdf
Official FDA record: K261570
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.