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 K151947
Device Name LightSheer Desire Light Laser System
Applicant
Lumenis, Ltd.
6 Hakidma St. P.O. Box 240
Yokneam Industrial Park
Yokneam,  IL 2069204
Applicant Contact ELISSA BURG
Correspondent
Lumenis, Ltd.
6 Hakidma St. P.O. Box 240
Yokneam Industrial Park
Yokneam,  IL 2069204
Correspondent Contact ELISSA BURG
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/15/2015
Decision Date 08/12/2015
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
-
-