• 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 fat reducing low level laser
510(k) Number K130922
Device Name ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
Applicant
ERCHONIA MEDICAL, INC.
33 Golden Eagle Lane
littleton,  CO  80127
Applicant Contact kevin walls
Correspondent
ERCHONIA MEDICAL, INC.
33 Golden Eagle Lane
littleton,  CO  80127
Correspondent Contact kevin walls
Regulation Number878.5400
Classification Product Code
OLI  
Subsequent Product Code
LYG  
Date Received04/03/2013
Decision Date 05/17/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-