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
510(k) Number K051259
Device Name VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
Applicant
Theralight, Inc.
2794 Loker Ave. W.,Suite 105
Carlsbad,  CA  92008
Applicant Contact KEVIN E DALY
Correspondent
Theralight, Inc.
2794 Loker Ave. W.,Suite 105
Carlsbad,  CA  92008
Correspondent Contact KEVIN E DALY
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
FTC  
Date Received05/16/2005
Decision Date 09/20/2005
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
-
-