FDA 510(k) Application Details - K113810

Device Classification Name	More FDA Info for this Device
510(K) Number	K113810
Device Name	MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
Applicant	ALMA LASERS INC. 485 HALF DAY RD. SUITW NO. 100 BUFFALO GROVE, IL 60089 US Other 510(k) Applications for this Company
Contact	TATIANA EPSTEIN 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	12/23/2011
Decision Date	03/08/2012
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