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 Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
510(k) Number K043353
Device Name OMEGA EXCEL/XP LASER SYSTEM
Applicant
Advanced Medical Technologies, Inc.
12101 Cullen Blvd. # A
Houston,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
Advanced Medical Technologies, Inc.
12101 Cullen Blvd. # A
Houston,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
NHN  
Date Received12/06/2004
Decision Date 07/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-