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 K131461
Device Name LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
Applicant
Led Intellectual Properties, LLC
16552 Von Karman Ave.
Irvine,  CA  92606
Applicant Contact STEVE MARCHESE
Correspondent
Led Intellectual Properties, LLC
16552 Von Karman Ave.
Irvine,  CA  92606
Correspondent Contact STEVE MARCHESE
Regulation Number878.4810
Classification Product Code
OLP  
Date Received05/20/2013
Decision Date 01/06/2014
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
-
-