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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K240314
Device Name MULA (K2-A1)
Applicant
Guangzhou Ciellulu Photoelectric Technology Co., Ltd.
11/F, Bldg. 1, Haihua Science & Technology Innovation
Park, # 62, Jinghu Ave., Huadu District,
Guangzhou,  CN 510800
Applicant Contact Jackie Zheng
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number878.4810
Classification Product Code
ONF  
Subsequent Product Code
GEX  
Date Received02/02/2024
Decision Date 08/21/2024
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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