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 System, Assisted Reproduction Laser
510(k) Number K192008
Device Name LaserShot M, NaviLase
Applicant
Vitrolife GmbH
Dr. -Pauling-Str.9
Bruckberg,  DE 84079
Applicant Contact Susanne Schweitzer
Correspondent
Vitrolife GmbH
Dr. -Pauling-Str.9
Bruckberg,  DE 84079
Correspondent Contact Susanne Schweitzer
Regulation Number884.6200
Classification Product Code
MRX  
Date Received07/29/2019
Decision Date 03/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-