• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K121487
Model LTC-900, LTC-1200
Device Name LITECURE THERAPY COMPACT
Original Applicant
LITECURE, LLC
250 corporate blvd.
suite b
newark,  DE  19702
Original Contact liang lu
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/18/2012
Decision Date 06/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee General & Plastic Surgery
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-