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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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
De Novo Number DEN090012
510(K) Number K083767
Device Name VIRULITE COLD SORE MACHINE
Requester
virulite llc
5405 alton parkway, 5a
suite 530
irvine,  CA  92604
Contact beky pine
Regulation Number878.4860
Classification Product Code
OKJ  
Date Received06/30/2009
Decision Date 10/18/2012
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
-
-