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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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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