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 Powered Laser Surgical Instrument
510(k) Number K031993
Device Name AURORA SR
Applicant
Syneron Medical, Ltd.
Appolo Bld., Industrial Zone
Yoqneam Illit,  IL 20692
Applicant Contact AMIR WALDMAN
Correspondent
Syneron Medical, Ltd.
Appolo Bld., Industrial Zone
Yoqneam Illit,  IL 20692
Correspondent Contact AMIR WALDMAN
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
GEI  
Date Received06/27/2003
Decision Date 08/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-