FDA 510(k) Application Details - K113702

Device Classification Name	More FDA Info for this Device
510(K) Number	K113702
Device Name	FOTONA XP ND: YAG LASER SYSTEM
Applicant	FOTONA D.D. STEGNE 7, LJUBLJANA 1000 SI Other 510(k) Applications for this Company
Contact	STOJAN TROST Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2011
Decision Date	03/28/2012
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