510(k) K201069

VibrantVue Scleral Saline by Dry Eye Innovations, LLC — Product Code MRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2020
Date Received
April 22, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Device Class
Class II
Regulation Number
886.5918
Review Panel
OP
Submission Type