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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K242440
Device Name Intense Pulsed Light Treatment System (LK-PT)
Applicant
Nanjing Bestview Laser S&T Co., Ltd.
1st & 2nd Floor, Bldg. 5, Area 1, Phase 2
Liandong U Valley Science And Technology Innovation Park
Nanjing,  CN 210000
Applicant Contact Jing Wang
Correspondent
Nanjing Bestview Laser S&T Co., Ltd.
1st & 2nd Floor, Bldg. 5, Area 1, Phase 2
Liandong U Valley Science And Technology Innovation Park
Nanjing,  CN 210000
Correspondent Contact Jing Wang
Regulation Number878.4810
Classification Product Code
ONF  
Date Received08/16/2024
Decision Date 11/14/2024
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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