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 K203544
Device Name UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
Applicant
Lumenis Ltd.
6 Hakidma Street PO Box 240
Yokneam,  IL 2069204
Applicant Contact Shlomit Segman
Correspondent
Lumenis Ltd.
6 Hakidma Street PO Box 240
Yokneam,  IL 2069204
Correspondent Contact Shlomit Segman
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/04/2020
Decision Date 12/24/2020
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
-
-