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 Confocal Optical Imaging
510(k) Number K132475
Device Name FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
Applicant
Fluoptics
8 Snowberry Court
Orinda,  CA  94563
Applicant Contact MICHAEL A DANIEL
Correspondent
Fluoptics
8 Snowberry Court
Orinda,  CA  94563
Correspondent Contact MICHAEL A DANIEL
Regulation Number876.1500
Classification Product Code
OWN  
Date Received08/07/2013
Decision Date 05/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-