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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 Bldg. # 1301, Sightseeing Rd.
Xinlan Community, Guanlan St., Longhua District
Shenzhen,  CN 518110
Applicant Contact Tse Adrian
Correspondent
Shenzhen Soga Technology Co., Ltd.
D906, Yinxing Technology Bldg. # 1301, Sightseeing Rd.
Xinlan Community, Guanlan St., 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
Predetermined Change
Control Plan Authorized		 No
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