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 K060792
Device Name ILLUMIMED
Applicant
Photoactif, LLC
1959 S. Power Rd.
Suite 103-313
Mesa,  AZ  85206
Applicant Contact JEREMY SHELLMAN
Correspondent
Photoactif, LLC
1959 S. 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
Predetermined Change
Control Plan Authorized		 No
-
-