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 K071943
Device Name SERENITY PRO PSF SYSTEM
Applicant
INOLASE 2002, LTD.
291 Hillside Avenue
Somerset,  MA  02726
Applicant Contact GEORGE J HATTUB
Correspondent
INOLASE 2002, LTD.
291 Hillside Avenue
Somerset,  MA  02726
Correspondent Contact GEORGE J HATTUB
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/13/2007
Decision Date 08/10/2007
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
-
-