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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 Hair Removal
510(k) Number K242710
Device Name Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
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
OHT  
Date Received09/09/2024
Decision Date 12/06/2024
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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