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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.
Room A701, Jinhong Park Incubation Building, No.229,
Tongzipo West Road, 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, No. 3101-90
Qianhai Road
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
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