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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Dental, Soft Tissue
510(k) Number K230047
Device Name Medical Diode Laser Systems
Applicant
Gigaalaser Company Ltd.
304, 306, 3F No.3 plant, Building B10
Wuhan Hi-Tech Medical Device Industrial Park
Wuhan,  CN 430206
Applicant Contact Xinxing Nie
Correspondent
Gigaalaser Company Ltd.
304, 306, 3F No.3 plant, Building B10
Wuhan Hi-Tech Medical Device Industrial Park
Wuhan,  CN 430206
Correspondent Contact Xinxing Nie
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Codes
EEG   GEX   ILY  
Date Received01/06/2023
Decision Date 03/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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