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 Light Based Non-Laser Surgical Instrument
510(k) Number K250224
Device Name handLITE (TN19S)
Applicant
Ismart Developments, Ltd.
129 Green Lanes
Wylde Green
Birmingham,  GB B73 5LT
Applicant Contact Susan D'Arcy
Correspondent
Ismart Developments, Ltd.
129 Green Lanes
Wylde Green
Birmingham,  GB B73 5LT
Correspondent Contact Susan D'Arcy
Regulation Number878.4810
Classification Product Code
ONE  
Date Received01/27/2025
Decision Date 04/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-