FDA 510(k) Application Details - K152095

Device Classification Name Booth, Sun Tan

  More FDA Info for this Device
510(K) Number K152095
Device Name Booth, Sun Tan
Applicant COSMEDICO LIGHT, INC.
233 LIBBEY INDUSTRIAL PARKWAY
WEYMOUTH, MA 02189 US
Other 510(k) Applications for this Company
Contact STEVEN SCHLITT
Other 510(k) Applications for this Contact
Regulation Number 878.4635

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

  More FDA Info for this Product Code
Date Received 07/28/2015
Decision Date 10/28/2015
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