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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Fluorescence Caries Detection
510(k) Number K252464
Device Name Surgical Microscope (OMS2360, OMS2380)
Applicant
Zumax Medical Co., Ltd.
5 Zhiying St., Suzhou New District,
Suzhou,  CN 215129
Applicant Contact Alfred Hee
Correspondent
Suzhou Device Innovation Medical Consulting Co., Ltd.
Rm. 1001, Bldg. 19, # 3188 Renmin Rd.
Suzhou,  CN 215000
Correspondent Contact Mike Gu
Regulation Number872.1745
Classification Product Code
NBL  
Subsequent Product Code
EPT  
Date Received08/06/2025
Decision Date 04/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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