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510(k) K182984

MaxiTears Contacts PF by Omnivision AG — Product Code MRC

K182984 is an FDA 510(k) premarket notification submitted by Omnivision AG for the device "MaxiTears Contacts PF". The FDA issued a decision of Substantially Equivalent on July 24, 2019. 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 24, 2019
Date Received
October 29, 2018
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