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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 K220381
Device Name Diode Laser Therapy Systems
Applicant
Beijing LaserTell Medical Co., Ltd.
Block1, No.12 Jingsheng South 2nd Road, JQ Science Park,
Tongzhou District
Beijing,  CN 101149
Applicant Contact Zeng Xun
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/10/2022
Decision Date 05/20/2022
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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