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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 K253309
Device Name SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)
Applicant
Shenzhen Soga Technology Co., Ltd.
Rm. 102, 2nd Floor & Rm. 302, 3rd Floor, Bldg. 1,
Second Industrial Zone,# 16, Guanghui Rd.,
Shenzhen,  CN 318110
Applicant Contact Zhang Sha
Correspondent
Shenzhen Soga Technology Co., Ltd.
Rm. 102, 2nd Floor & Rm. 302, 3rd Floor, Bldg. 1,
Second Industrial Zone,# 16, Guanghui Rd.,
Shenzhen,  CN 318110
Correspondent Contact Zhang Sha
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Code
GEX  
Date Received09/29/2025
Decision Date 05/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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