FDA 510(k) Application Details - K093963

Device Classification Name Over-The-Counter Powered Light Based Laser For Acne

  More FDA Info for this Device
510(K) Number K093963
Device Name Over-The-Counter Powered Light Based Laser For Acne
Applicant SILVER BAY, LLC
1431 Tallevast Road
Sarasota, FL 34243 US
Other 510(k) Applications for this Company
Contact PETER NESBITT
Other 510(k) Applications for this Contact
Regulation Number 878.4810

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

  More FDA Info for this Product Code
Date Received 12/23/2009
Decision Date 08/27/2010
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