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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K232992
Device Name 10THERMA
Applicant
Tentech, Inc.
3f, Hyungkyung Bldg., 611, Seolleung-Ro, Gangnam-Gu,
Seoul,  KR 06103
Applicant Contact Dongok Han
Correspondent
Bt Solutions, Inc.
Unit 904, Eonju-Ro 86-Gil 5, Gangnam-Gu
Seoul,  KR 06210
Correspondent Contact Do Hyun Kim
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/22/2023
Decision Date 12/20/2023
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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