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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 K214008
Device Name Dental diode laser
Applicant
Shenzhen Soga Technology Co., Ltd.
D906, Yinxing Technology Building No. 1301, Sightseeing Road
Xinlan Community, Guanlan Street, Longhua District
Shenzhen,  CN 518110
Applicant Contact Tse Adrian
Correspondent
Shenzhen Soga Technology Co., Ltd.
D906, Yinxing Technology Building No. 1301, Sightseeing Road
Xinlan Community, Guanlan Street, Longhua District
Shenzhen,  CN 518110
Correspondent Contact Tse Adrian
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Code
GEX  
Date Received12/22/2021
Decision Date 05/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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