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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 K250936
Device Name Q-Switched Nd:YAG Laser (SHE-LSP101-1)
Applicant
Beijing Sano Laser S&T Development Co.,Ltd
Rm. 7-201,#1,Caida 3rd St.,Nancai Town
Shunyi District
Beijing,  CN
Applicant Contact Zhu Qi
Correspondent
Beijing Sano Laser S&T Development Co.,Ltd
Rm. 7-201,#1,Caida 3rd St.,Nancai Town
Shunyi District
Beijing,  CN
Correspondent Contact Zhu Qi
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/28/2025
Decision Date 06/12/2025
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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