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 Surgical Smoke Precipitator
510(k) Number K240868
Device Name Ultravision2™ IonPencil
Applicant
Alesi Surgical Limited
Cardiff Medicentre, Heath Park, Cardiff, Cf14 4uj
Cardiff,  GB
Applicant Contact Pravin Patel
Correspondent
Alesi Surgical Limited
Cardiff Medicentre, Heath Park, Cardiff, Cf14 4uj
Cardiff,  GB
Correspondent Contact Pravin Patel
Regulation Number878.5050
Classification Product Code
PQM  
Subsequent Product Code
GEI  
Date Received03/29/2024
Decision Date 08/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-