K240297
- 510(k) number
- K240297
- Device name
- Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)
- Applicant
- Us Medical Innovations, LLC MD · US
- Product code
- OAB — Low Energy Direct Current Thermal Ablation System
- Decision date
- 2024-05-03
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240297.pdf
Official FDA record: K240297
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.