• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name ophthalmic femtosecond laser
510(k) Number K122386
Device Name VICTUS FEMTOSECOND LASER PLATFORM
Original Applicant
TECHNOLAS PERFECT VISION GMBH
po box 17190
anaheim,  CA  92817 -7190
Original Contact betty m johnson
Regulation Number886.4390
Classification Product Code
OOE  
Subsequent Product Code
HQF  
Date Received08/06/2012
Decision Date 02/08/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-