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 K240497
Device Name Smartxide Tetra Pro
Applicant
El.En S.P.A.
Via Baldanzese 17
Calenzano,  IT 50141
Applicant Contact Paolo Peruzzi
Correspondent
El.En S.P.A.
Via Baldanzese 17
Calenzano,  IT 50141
Correspondent Contact Paolo Peruzzi
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/20/2024
Decision Date 03/12/2024
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
-
-