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 Lamp, Infrared, Therapeutic Heating
510(k) Number K113668
Device Name HEALITE II SYSTEM
Applicant
LUTRONIC CORPORATION
6 NESHAMINY INTERPLEX,
SUITE 207
TREVOSE,  PA  19053
Applicant Contact JHUNG WON VOJIR
Correspondent
LUTRONIC CORPORATION
6 NESHAMINY INTERPLEX,
SUITE 207
TREVOSE,  PA  19053
Correspondent Contact JHUNG WON VOJIR
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/13/2011
Decision Date 06/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-