K240396
- 510(k) number
- K240396
- Device name
- Elite iQ PRO (M122K1)
- Applicant
- Cynosure, LLC MA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-03-08
- Date received
- 2024-02-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240396.pdf
Official FDA record: K240396
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.