FDA 510(k) Application Details - K171433

Device Classification Name Light Based Over-The-Counter Hair Removal

  More FDA Info for this Device
510(K) Number K171433
Device Name Light Based Over-The-Counter Hair Removal
Applicant Home Skinovations Ltd.
Tabor Building, Shaar Yokneam
Yoqneam Illit IL
Other 510(k) Applications for this Company
Contact Amit Goren
Other 510(k) Applications for this Contact
Regulation Number 878.4810

  More FDA Info for this Regulation Number
Classification Product Code OHT
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 05/15/2017
Decision Date 08/11/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact