• 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 K122125
Model M077XX
Device Name ASA LASER SH1
Original Applicant
EL.EN. ELECTRONIC ENGINEERING SPA
17 via baldanzese
calenzano,  IT 50041
Original Contact paolo peruzzi
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/18/2012
Decision Date 01/25/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-