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 Camera, Ophthalmic, Ac-Powered
510(k) Number K230627
Device Name Zilia Ocular FC (ZIL-10002)
Applicant
Zilia, Inc.
125 Charest Blvd. E.
Suite 400
Quebec City,  CA G1K3G5
Applicant Contact Sauvageau Patrick
Correspondent
Ultra Life Science Solutions, Inc.
2811 Milton Ave. #409
Janesville,  WI  53545
Correspondent Contact Christina Henza
Regulation Number886.1120
Classification Product Code
HKI  
Date Received03/06/2023
Decision Date 11/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-