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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 K242943
Device Name Q Switched Nd:YAG Laser machine (QNHF-01)
Applicant
Beijing Nubway S&T Co., Ltd.
202,#5 Workshop, #1 Caida 3rd Rd. Nancaishunyi District
Beijing,  CN 100000
Applicant Contact Xiting Fan
Correspondent
Microkn Medical Technology Service (Shanghai)Co.,Ltd Company
Rm. 901, Huafa Center, 889 Pinglu Rd.
Jing'An District, Shanghai
Shanghai,  CN 200040
Correspondent Contact Owen He
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/25/2024
Decision Date 03/03/2025
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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