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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 K261701
Device Name Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
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 Received05/22/2026
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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