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 keratome, ac-powered
510(k) Number K173371
Device Name VisuMax Femtosecond Laser
Applicant
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin,  CA  94568
Applicant Contact Todd Otani
Correspondent
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin,  CA  94568
Correspondent Contact Todd Otani
Regulation Number886.4370
Classification Product Code
HNO  
Date Received10/27/2017
Decision Date 04/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-