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 Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K200746
Device Name IPL Treatment Systems
Applicant
Shanghai Apolo Medical Technology Co., Ltd.
4f, Bldg. A, #388, Yindu Rd., Xuhui District
Shanghai,  CN 200231
Applicant Contact Felix Li
Correspondent
Shanghai Apolo Medical Technology Co., Ltd.
4f, Bldg. A, #388, Yindu Rd., Xuhui District
Shanghai,  CN 200231
Correspondent Contact Felix Li
Regulation Number878.4810
Classification Product Code
ONF  
Date Received03/23/2020
Decision Date 05/15/2020
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
Predetermined Change
Control Plan Authorized		 No
-
-