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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 K251836
Device Name Dermatrix Duo
Applicant
Shenzhen Gsd Technology Co., Ltd.
Bldg. A, Junsd Hi-Tech Park, Watch & Clock Base
Guangming District
Shenzhen,  CN
Applicant Contact Gordon Wang
Correspondent
Shenzhen Gsd Technology Co., Ltd.
Bldg. A, Junsd Hi-Tech Park, Watch & Clock Base
Guangming District
Shenzhen,  CN
Correspondent Contact Gordon Wang
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
PBX  
Date Received06/16/2025
Decision Date 02/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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