• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name powered laser surgical instrument
510(k) Number K060304
Device Name PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940
Original Applicant
BIOTEX, INC.
8058 el rio st.
houston,  TX  77054
Original Contact matthew fox
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/06/2006
Decision Date 03/21/2006
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
-
-