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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 K252745
Device Name Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
Applicant
Micro-Energy Medical Technology Co., Ltd.
Section B4301, B4701 And B4901, # 13, Baolan Rd.
Kengzi St., Pingshan District
Shenzhen,  CN 518118
Applicant Contact Danning Zhu
Correspondent
Micro-Energy Medical Technology Co., Ltd.
Section B4301, B4701 And B4901, # 13, Baolan Rd.
Kengzi St., Pingshan District
Shenzhen,  CN 518118
Correspondent Contact Danning Zhu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/29/2025
Decision Date 12/12/2025
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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