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 Powered Laser Surgical Instrument With Microbeam\Fractional Output
510(k) Number K162398
Device Name CO2 Laser Therapy Systems
Applicant
BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO.
ROOM 305, NO.43, XIZHIMEN NORTH STREET, HAIDIAN DISTRICT
BEIJING,  CN 100044
Applicant Contact XIN WANG
Correspondent
GUANGZHOU OSMUNDA MEDICAL DEVICE TECHNOLOGY SERVICE CO., LTD
7TH FLOOR, JINGUI BUSINESS BUILDING, NO.982 CONGYUN RD
BAIYUN DISTRICT
GUANGZHOU,  CN 510420
Correspondent Contact MIKE GU
Regulation Number878.4810
Classification Product Code
ONG  
Subsequent Product Code
GEX  
Date Received08/26/2016
Decision Date 07/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-