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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K253833
Device Name Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
Applicant
Shenzhen Jianchao Intelligent Technology Co., Ltd.
Rm301, Bldg.25, #68 Hexiu W. Rd., Fuhai St., Baoan
Shenzhen,  CN 518107
Applicant Contact Fred Li
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90
Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
NFO   OLP  
Date Received12/01/2025
Decision Date 01/30/2026
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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