510(k) K240297
K240297 is an FDA 510(k) premarket notification submitted by Us Medical Innovations, LLC for the device "Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)". The FDA issued a decision of Substantially Equivalent on May 3, 2024. The device falls under product code OAB (Low Energy Direct Current Thermal Ablation System), a Class II device regulated under 21 CFR 878.4400. Us Medical Innovations, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2024
- Date Received
- February 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Low Energy Direct Current Thermal Ablation System
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Ablation of soft tissue