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 Confocal Optical Imaging
510(k) Number K243591
Device Name OPTOVISION Endoscopic Light Source Unit
Applicant
Optosurgical, LLC
6751 Columbia Gateway Dr., Suite 300
Office 313
Columbia,  MD  21046
Applicant Contact Yoseph Kim
Correspondent
Optosurgical, LLC
6751 Columbia Gateway Dr., Suite 300
Office 313
Columbia,  MD  21046
Correspondent Contact Yoseph Kim
Regulation Number876.1500
Classification Product Code
OWN  
Date Received11/20/2024
Decision Date 02/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-