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 K080318
Device Name ALMA LASER NIR MODULE
Applicant
ALMA LASERS LTD.
HALAMISH ST. POB 3021
INDUSTRIAL PARK
CAESAREA,  IL 38900
Applicant Contact TATIANA EPSTEIN
Correspondent
ALMA LASERS LTD.
HALAMISH ST. POB 3021
INDUSTRIAL PARK
CAESAREA,  IL 38900
Correspondent Contact TATIANA EPSTEIN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received02/06/2008
Decision Date 03/07/2008
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
-
-