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 Laser, Comb, Hair
510(k) Number K122950
Device Name LASER HELMET
Applicant
Theradome, Inc.
4900 Hopyard Rd.
Suite 100
Pleasanton,  CA  94588
Applicant Contact LARRY PETERSEN
Correspondent
Theradome, Inc.
4900 Hopyard Rd.
Suite 100
Pleasanton,  CA  94588
Correspondent Contact LARRY PETERSEN
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/25/2012
Decision Date 06/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-