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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 K252063
Device Name Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)
Applicant
Wuhan Dimed Laser Technology Co., Ltd.
Rm. 311, 313, 315, Hubei Guozhi Patent Venture Incubator
Bldg., 327-1 Minzu Ave.
Wuhan,  CN 430223
Applicant Contact Qiao Cheng
Correspondent
Linnwell International Certification Consulting Co., Ltd.
Rm. 310, Bldg. 2, # 110 Xinjunhuan Rd.
Minhang District
Shanghai,  CN 201112
Correspondent Contact Yuling Chen
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/01/2025
Decision Date 09/25/2025
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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