Optixon 1-Day
K-Number: K201013 · 2020-09-18
ApplicantOptixon, Inc.
Decision Date2020-09-18
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Optixon 1-Day is a medical device manufactured by Optixon, Inc.. It received FDA 510(k) clearance on 2020-09-18 under approval number K201013. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Optixon 1-Day?
Optixon 1-Day is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by Optixon, Inc.. The 510(k) number is K201013.
When was Optixon 1-Day approved by the FDA?
Optixon 1-Day received FDA 510(k) clearance on 2020-09-18, under approval number K201013.
What company makes Optixon 1-Day?
Optixon 1-Day is manufactured by Optixon, Inc..
What is the FDA product code for Optixon 1-Day?
The FDA product code for Optixon 1-Day is LPL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.