• 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 laser, ophthalmic
510(k) Number K122202
Model LR1532
Device Name ELLEX 2RT
Original Applicant
ELLEX MEDICAL PTY. LTD.
82 gilbert st.
adelaide, south australia,  AS 5000
Original Contact kevin howard
Regulation Number886.4390
Classification Product Code
HQF  
Date Received07/25/2012
Decision Date 07/01/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-