FDA 510(k) Application Details - K120938

Device Classification Name	More FDA Info for this Device
510(K) Number	K120938
Device Name	THE PL-1064 LASER SYSTEM
Applicant	SHEAUMANN LASER, INC 189 WINDING OAKS LANE OVIEDO, FL 32765 US Other 510(k) Applications for this Company
Contact	TIMOTHY J SHEA 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	03/22/2012
Decision Date	09/24/2012
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