• 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 K060792
Device Name ILLUMIMED
Applicant
PHOTOACTIF, LLC
1959 SOUTH POWER RD
SUITE 103-313
MESA,  AZ  85206
Applicant Contact JEREMY SHELLMAN
Correspondent
PHOTOACTIF, LLC
1959 SOUTH POWER RD
SUITE 103-313
MESA,  AZ  85206
Correspondent Contact JEREMY SHELLMAN
Regulation Number890.5500
Classification Product Code
ILY  
Subsequent Product Code
GEX  
Date Received03/23/2006
Decision Date 12/01/2006
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
-
-