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, Slit-Scanning
510(k) Number K243878
Device Name CLARUS (700)
Applicant
Carl Zeiss Meditec, Inc.
5300 Central Pkwy.
Dublic,  CA  94568
Applicant Contact Tanesha Bland
Correspondent
Carl Zeiss Meditec, Inc.
5300 Central Pkwy.
Dublic,  CA  94568
Correspondent Contact Tanesha Bland
Regulation Number886.1120
Classification Product Code
QER  
Date Received12/18/2024
Decision Date 04/17/2025
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
-
-