Luminopia
K-Number: K243819 · 2025-04-09
ApplicantLuminopia, Inc.
Decision Date2025-04-09
Product CodeQQU
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Luminopia is a medical device manufactured by Luminopia, Inc.. It received FDA 510(k) clearance on 2025-04-09 under approval number K243819. 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?
Luminopia is a medical device that received FDA 510(k) clearance on 2025-04-09. It is manufactured by Luminopia, Inc.. The 510(k) number is K243819.
When was Luminopia approved by the FDA?
Luminopia received FDA 510(k) clearance on 2025-04-09, under approval number K243819.
What company makes Luminopia?
Luminopia is manufactured by Luminopia, Inc..
What is the FDA product code for Luminopia?
The FDA product code for Luminopia 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.