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 K170068
Device Name Softcure 96
Applicant
Wellray Medical Laser, Inc.
216 Moores Run Rd.
Wardensville,  WV  26851
Applicant Contact Richard O DeRoberts
Correspondent
Wellray Medical Laser, Inc.
216 Moores Run Rd.
Wardensville,  WV  26851
Correspondent Contact Richard O DeRoberts
Regulation Number890.5500
Classification Product Code
ILY  
Date Received01/09/2017
Decision Date 05/05/2017
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
-
-