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 Lamp, Infrared, Therapeutic Heating
510(k) Number K041679
Device Name COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT
Applicant
Onyx Medical, Inc.
445 Coloma St.
Sausalito,  CA  94965
Applicant Contact ROGER MACHSON
Correspondent
Onyx Medical, Inc.
445 Coloma St.
Sausalito,  CA  94965
Correspondent Contact ROGER MACHSON
Regulation Number890.5500
Classification Product Code
ILY  
Date Received06/21/2004
Decision Date 12/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-