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 K100228
Device Name VERSAPULSE MODEL P20 LASER SYSTEM
Applicant
LUMENIS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact DOUG STANTE
Correspondent
LUMENIS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact DOUG STANTE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/26/2010
Decision Date 02/24/2010
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
-
-