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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 K222432
Device Name IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
Applicant
Hunan Guangye Biotechnology Co., Ltd.
Rm. A701, Jinhong Park Incubation Bldg., #229,
Tongzipo W. Rd., High-Tech Development
Changsha City,  CN 410006
Applicant Contact Eileen Li
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number878.4810
Classification Product Code
OHT  
Date Received08/12/2022
Decision Date 10/11/2022
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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