FDA 510(k) Application Details - K091625

Device Classification Name Powered Laser Surgical Instrument

  More FDA Info for this Device
510(K) Number K091625
Device Name Powered Laser Surgical Instrument
Applicant LIGHT AGE, INC.
500 APGAR DRIVE
SOMERSET, NJ 08873-1150 US
Other 510(k) Applications for this Company
Contact ELIZABETH REDDINGTON
Other 510(k) Applications for this Contact
Regulation Number 878.4810

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

  More FDA Info for this Product Code
Date Received 06/03/2009
Decision Date 11/03/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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