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 Light Based Treatment For Cold Sores Herpes Simplex Virus-1
510(k) Number K222205
Device Name Cold Sore Device (Model: QPZ-01)
Applicant
Light Tree Ventures Europe B.V.
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands
Hague,  NL
Applicant Contact Alain Dijkstra
Correspondent
Light Tree Ventures Europe B.V.
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands
Hague,  NL
Correspondent Contact Alain Dijkstra
Regulation Number878.4860
Classification Product Code
OKJ  
Date Received07/25/2022
Decision Date 10/07/2022
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
-
-