510(k) K173157

Dr's Light2 by Good Doctors Co., Ltd. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2018
Date Received
September 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
Review Panel
DE
Submission Type