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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Energy Direct Current Thermal Ablation System
510(k) Number K240297
Device Name Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
Applicant
Us Medical Innovations, LLC
6930 Carroll Ave.
10th Floor, Suite 1000
Tacoma Park,  MD  20912
Applicant Contact Jerome Canady
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Audrey Swearingen
Regulation Number878.4400
Classification Product Code
OAB  
Subsequent Product Code
GEI  
Date Received02/01/2024
Decision Date 05/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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