FDA 510(k) Application Details - K092195

Device Classification Name Massager, Vacuum, Light Induced Heating

  More FDA Info for this Device
510(K) Number K092195
Device Name Massager, Vacuum, Light Induced Heating
Applicant CUTERA, INC.
3240 BAYSHORE BLVD
BRISBANE, CA 94005 US
Other 510(k) Applications for this Company
Contact KATHY MAYNOR
Other 510(k) Applications for this Contact
Regulation Number 878.4810

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

  More FDA Info for this Product Code
Date Received 07/21/2009
Decision Date 10/01/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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