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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K260179
Device Name VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
Applicant
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
29/F, Block B, Tiley Central Plz., #195 Haide 3rd Rd.
Nanshan District
Shenzhen,  CN 518064
Applicant Contact Elin Zhou
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Bing Huang
Regulation Number882.5890
Classification Product Code
NFO  
Date Received01/21/2026
Decision Date 06/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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