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 powered laser surgical instrument
510(k) Number K100746
Device Name FIBER ONE
Applicant
AMERICAN MEDICAL SYSTEMS
155-A MOFFETT PARK DRIVE
SUITE 210
SUNNYVALE,  CA  94089
Applicant Contact DARLENE CROCKETT-BILLIG
Correspondent
AMERICAN MEDICAL SYSTEMS
155-A MOFFETT PARK DRIVE
SUITE 210
SUNNYVALE,  CA  94089
Correspondent Contact DARLENE CROCKETT-BILLIG
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/16/2010
Decision Date 06/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-