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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 K261674
Device Name Skin Air Cooling System (QALF-01)
Applicant
Beijing Nubway S&T Co., Ltd.
202,#5 Workshop, #1 Caida 3rd Rd. Nancai Shunyi District, Be
Beijing,  CN 101300
Applicant Contact Xiting Fan
Correspondent
Tianjin Xinnuocheng Medical Technology Co., LTD.
Rm. 1505, Wanhai Bldg., Dazhigu Sub-District
Hedong District
Tianjin,  CN 300170
Correspondent Contact Lena Zhang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/21/2026
Decision Date 07/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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