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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 K250206
Device Name Diode laser system (Night Universe; Predator)
Applicant
Ivylaser (Beijing) Technology Co.,Ltd
Rm. 411, Bldg. 3, # 2 Shengfang Rd., Daxing District,
Beijing,  CN
Applicant Contact Yuan Xiujuan
Correspondent
Microkn Medical Technology Service (Shanghai) Co., Ltd.
Rm. 901, #889, Pinglu Rd., Jing'An District
Shanghai,  CN
Correspondent Contact Owen He
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/24/2025
Decision Date 04/24/2025
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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