• 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, image processing, radiological
510(k) Number K081656
Device Name VISUALASE THERMAL THERAPY SYSTEM
Applicant
BIOTEX, INC.
8058 EL RIO ST.
houston,  TX  77054 -4185
Applicant Contact roger mcnichols
Correspondent
BIOTEX, INC.
8058 EL RIO ST.
houston,  TX  77054 -4185
Correspondent Contact roger mcnichols
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
FRN   GEX  
Date Received06/12/2008
Decision Date 09/10/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-