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 K133486
Device Name STELLARIS PC VISION ENHANCEMENT SYSTEM
Applicant
BAUSCH & LOMB
3365 TREE CT. INDUSTRIAL BLVD
ST. LOUIS,  MO  63122
Applicant Contact TIMOTHY W CAPEHART
Correspondent
BAUSCH & LOMB
3365 TREE CT. INDUSTRIAL BLVD
ST. LOUIS,  MO  63122
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HQE   HQF  
Date Received11/13/2013
Decision Date 03/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-