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 Laser, Ophthalmic
510(k) Number K232051
Device Name VISULAS green
Applicant
Carl Zeiss Meditec
5300 Central Pkwy.
Dublic,  CA  94568
Applicant Contact Tanesha Bland
Correspondent
Carl Zeiss Meditec
5300 Central Pkwy.
Dublic,  CA  94568
Correspondent Contact Tanesha Bland
Regulation Number886.4390
Classification Product Code
HQF  
Date Received07/10/2023
Decision Date 10/24/2023
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
-
-