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 Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
510(k) Number K895864
Device Name MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP
Applicant
Lasag AG
6440 Flying Cloud Dr., #117
Eden Prairie,  MN  55344
Applicant Contact MURRAY P HARRIS
Correspondent
Lasag AG
6440 Flying Cloud Dr., #117
Eden Prairie,  MN  55344
Correspondent Contact MURRAY P HARRIS
Regulation Number886.4392
Classification Product Code
LXS  
Date Received10/03/1989
Decision Date 12/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-