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 Light Based Over-The-Counter Hair Removal
510(k) Number K140381
Device Name SENSILIGHT/ SENSILIGHT PLUS
Applicant
El Global Trade, Ltd.
Tzoran 4th St.
Netanya,  IL 42504
Applicant Contact SHLOMIT SEGMAN
Correspondent
El Global Trade, Ltd.
Tzoran 4th St.
Netanya,  IL 42504
Correspondent Contact SHLOMIT SEGMAN
Regulation Number878.4810
Classification Product Code
OHT  
Date Received02/14/2014
Decision Date 08/08/2014
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
-
-