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 Lens, Contact (Other Material) - Daily
510(k) Number K171950
Device Name Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
Applicant
Visionary Optics, LLC
1325 Progress Dr.
Front Royal,  VA  22630
Applicant Contact Donald R. Sanders
Correspondent
Eyereg Consulting, Inc.
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5916
Classification Product Code
HQD  
Date Received06/29/2017
Decision Date 08/16/2017
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
-
-