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 Tonometer, Ac-Powered
510(k) Number K162067
Device Name VX130 Ophthalmic Diagnostic Device
Applicant
Luneau Sas
1 Ave. De Malaguet
Prunay Le Gillon,  FR 28360
Applicant Contact ISABELLE DURAND
Correspondent
Luneau Sas
1 Ave. De Malaguet
Prunay Le Gillon,  FR 28360
Correspondent Contact ISABELLE DURAND
Regulation Number886.1930
Classification Product Code
HKX  
Subsequent Product Code
MXK  
Date Received07/26/2016
Decision Date 04/24/2017
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
-
-