510(k) K161461

BostonSight PD Prosthetic Device by Bostonsight — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2016
Date Received
May 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Other Material) - Daily
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type