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510(k) K201069

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

K201069 is an FDA 510(k) premarket notification submitted by Dry Eye Innovations, LLC for the device "VibrantVue Scleral Saline". The FDA issued a decision of Substantially Equivalent on July 31, 2020. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918.

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

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FDA data resources