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 endoilluminator
510(k) Number K202670
Device Name Nam illumination probe with chopper
Applicant
Oculight Ltd.
Seongnamdaelo 1342, B111
Seongnam-si,  KR 13120
Applicant Contact Jinman Kim
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Road
Shrewsbury,  VT  05738
Correspondent Contact Robert Packard
Regulation Number876.1500
Classification Product Code
MPA  
Date Received09/14/2020
Decision Date 08/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-