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 Orthodontic Led Accessory
510(k) Number K143120
Device Name OrthoPulse
Applicant
BIOLUX RESEARCH LTD.
825 POWELL STREET, SUITE 220
VANCOUVER,  CA V6A 1H7
Applicant Contact Kevin Strange
Correspondent
HOGAN LOVELLS US LLP
1835 MARKET ST 29TH FL
PHILADELPHIA,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number872.5470
Classification Product Code
PLH  
Date Received10/30/2014
Decision Date 07/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Clinical Trials NCT02267811
NCT02267824
NCT02267837
NCT02267850
Reviewed by Third Party No
Combination Product No
-
-