Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name laser, dental, soft tissue
510(k) Number K211150
Device Name Dental diode laser, SOGA Laser, ILaser II
Applicant
Shenzhen Soga Technology Co., Ltd.
D906, Yinxing Technology Building No. 1301, Sightseeing
Road, Xinlan Community, Guanlan Street
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
Shenzhen,  CN 518110
Correspondent Contact Tse Adrian
Regulation Number878.4810
Classification Product Code
NVK  
Date Received04/19/2021
Decision Date 07/01/2022
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
-
-