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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 K242941
Device Name CO2 Laser Therapy Systems (SHE-LSP003-1)
Applicant
Beijing Sano Laser S&T Development Co.,Ltd
Rm. 201, 2nd Floor, #7 Bldg., Maohuagongchang
#1 Caida Third St., Nancai Town, Shunyi District
Beijing,  CN 101300
Applicant Contact Li Zhengrong
Correspondent
Microkn Medical Technology Service (Shanghai)Co.,Ltd Company
Rm. 901, Huafa Center, 889 Pinglu Rd., Jing 'An District
Shanghai,  CN 200040
Correspondent Contact Owen He
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/25/2024
Decision Date 01/27/2025
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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