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 Vitrectomy, Instrument Cutter
510(k) Number K220030
Device Name Vista Ophthalmics Vitrectomy Probe
Applicant
Vista Ophthalmics, LLC
23510 Kingsland Blvd. Suite 200
Katy,  TX  77494
Applicant Contact Don Knowles
Correspondent
Regulatory Pathways Group, Inc.
340 S. Lemon Ave. #2471
Walnut,  CA  91789
Correspondent Contact Debe Deck
Regulation Number886.4150
Classification Product Code
MLZ  
Date Received01/05/2022
Decision Date 05/04/2022
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
-
-