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 Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K081307
Device Name OMNILUX CLEAR-U
Applicant
Photo Therapeutics, Inc.
2720 Loker Ave. W.
Carlsbad,  CA  92010
Applicant Contact SUE DARCY
Correspondent
Photo Therapeutics, Inc.
2720 Loker Ave. W.
Carlsbad,  CA  92010
Correspondent Contact SUE DARCY
Regulation Number878.4810
Classification Product Code
OLP  
Date Received05/08/2008
Decision Date 01/16/2009
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
Predetermined Change
Control Plan Authorized		 No
-
-