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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 With Microbeam\Fractional Output
510(k) Number K192350
Device Name Medical Non-Ablative Fractional Laser Systems
Applicant
Wingderm Electro-Optics , Ltd.
Rm.312, Bldg. D-3, Dongsheng Science Park,
#66 Of Xixiaokou Rd., Haidian
Beijing,  CN 100192
Applicant Contact Zhou Juan
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
ONG  
Date Received08/29/2019
Decision Date 04/30/2020
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
Recalls CDRH Recalls
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