K240297 is an FDA 510(k) clearance for the Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS). This device is classified as a Low Energy Direct Current Thermal Ablation System (Class II - Special Controls, product code OAB).
Submitted by Us Medical Innovations, LLC (Tacoma Park, US). The FDA issued a Cleared decision on May 3, 2024, 92 days after receiving the submission on February 1, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Ablation Of Soft Tissue.
| 510(k) Number | K240297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2024 |
| Decision Date | May 03, 2024 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OAB - Low Energy Direct Current Thermal Ablation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Ablation Of Soft Tissue |