510(k) K143123

Synergetics PHOTON EX by Synergetics — Product Code MPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2015
Date Received
October 31, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type