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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K240520
Device Name Diode Laser Hair Removal System (SH-VD910)
Applicant
Beijing Sea Heart International Science and Technologyco.Ltd
Rm. 4009, Bldg. 4, Zhongke Jingwei Industrial Park
#8 Yongchang Middle Rd.,Economic And Technological Develo
Beijing,  CN 100176
Applicant Contact Xiaoli He
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5,
Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/23/2024
Decision Date 05/20/2024
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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