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510(k) K240297

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) by Us Medical Innovations, LLC — Product Code OAB

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

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