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 Lenses, Soft Contact, Daily Wear
510(k) Number K233856
Device Name Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal
Applicant
Alcon Laboratories, Inc.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Applicant Contact Sherri Lakota
Correspondent
Alcon / Ciba Vision GmbH
Industriering 1
Grosswallstadt,  DE 63868
Correspondent Contact Andreas Friese
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received12/05/2023
Decision Date 12/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-