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 K051548
Device Name IRRADIA MID - LASER (S3)
Applicant
Irradia AB
20101 SW Birch St. #272
Newport Beach,  CA  92660
Applicant Contact THEO RUSSO-LARSSON
Correspondent
Irradia AB
20101 SW Birch St. #272
Newport Beach,  CA  92660
Correspondent Contact THEO RUSSO-LARSSON
Regulation Number890.5500
Classification Product Code
ILY  
Date Received06/13/2005
Decision Date 10/24/2005
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
-
-