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 Unit, Phacofragmentation
510(k) Number K200207
Device Name xPORT S Lens Fragmentation System
Applicant
Carl Zeiss Meditec Cataract Technology, Inc.
8748 Technology Way
Reno,  NV  89521
Applicant Contact Gary Mocnik
Correspondent
Carl Zeiss Meditec Cataract Technology, Inc.
8748 Technology Way
Reno,  NV  89521
Correspondent Contact Gary Mocnik
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
MLZ  
Date Received01/28/2020
Decision Date 10/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-