• 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 light, ultraviolet, dermatological
510(k) Number K172273
Device Name 308nm Excimer System
Chongqing Peninsula Medical Technology Co., Ltd.
No.2-4, 2F Block I, Ke Yuan 4th Road, Jiulongpo District
Chongqing,  CN 400041
Applicant Contact Zhang Sudi
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, No.121 Science Road
Guangzhou Science Park
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number878.4630
Classification Product Code
Date Received07/28/2017
Decision Date 07/30/2018
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