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 Wrinkle Reduction
510(k) Number K162784
Device Name Silk'n HST
Applicant
Home Skinovations , Ltd.
Tabor Bldg., Shaar Yokneam
Yokneam,  IL 2069200
Applicant Contact Amit Goren
Correspondent
A. Stein – Regulatory Affairs Consulting , Ltd.
20 Hata’As St., Suite 102
Kfar Saba,  IL 4442520
Correspondent Contact Amit Goren
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
PAY  
Date Received10/03/2016
Decision Date 03/25/2017
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
-
-