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 Powered Laser Surgical Instrument With Microbeam\Fractional Output
510(k) Number K090525
Device Name LOI SYSTEM
Applicant
Palomar Medical Products, Inc.
82 Cambridge St.
Burlington,  MA  01803
Applicant Contact Sharon Timberlake
Correspondent
Palomar Medical Products, Inc.
82 Cambridge St.
Burlington,  MA  01803
Correspondent Contact Sharon Timberlake
Regulation Number878.4810
Classification Product Code
ONG  
Date Received02/26/2009
Decision Date 06/01/2009
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
-
-