• 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 powered laser surgical instrument
510(k) Number K122159
Model MEDILAS H30
Device Name DORNIER MEDILAS H30 SOLVO
Original Applicant
DORNIER MEDTECH AMERICA, INC.
1155 roberts blvd.
kennesaw,  GA  30144
Original Contact john hoffer
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/20/2012
Decision Date 02/01/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-