Luminopia One
K-Number: K221659 · 2022-11-04
ApplicantLuminopia, Inc.
Decision Date2022-11-04
Product CodeQQU
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Luminopia One is a medical device manufactured by Luminopia, Inc.. It received FDA 510(k) clearance on 2022-11-04 under approval number K221659. The device is classified under product code QQU. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Luminopia One?
Luminopia One is a medical device that received FDA 510(k) clearance on 2022-11-04. It is manufactured by Luminopia, Inc.. The 510(k) number is K221659.
When was Luminopia One approved by the FDA?
Luminopia One received FDA 510(k) clearance on 2022-11-04, under approval number K221659.
What company makes Luminopia One?
Luminopia One is manufactured by Luminopia, Inc..
What is the FDA product code for Luminopia One?
The FDA product code for Luminopia One is QQU.
Other Devices by Luminopia, Inc.
Related Devices (Code: QQU)
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.