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 diagnostic light, soft tissue detector
510(k) Number K102083
Device Name VELSCOPE VX
Applicant
LED DENTAL INC.
235-5589 BYRNE ROAD
BURNABY , BC,  CA V5J 3J1
Applicant Contact DAVID MORGAN
Correspondent
LED DENTAL INC.
235-5589 BYRNE ROAD
BURNABY , BC,  CA V5J 3J1
Correspondent Contact DAVID MORGAN
Regulation Number872.6350
Classification Product Code
NXV  
Date Received07/26/2010
Decision Date 11/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-