510(k) K171702

Exciplex308nm by Clarteis — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2017
Date Received
June 8, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Ultraviolet, Dermatological
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type