FDA 510(k)

Luminopia One

K-Number: K221659 · 2022-11-04

Decision Date2022-11-04

Product CodeQQU

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Luminopia One is the device name listed in this FDA 510(k) record. The listed applicant is Luminopia, Inc.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) 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. The listed applicant is Luminopia, Inc.. The 510(k) number is K221659.

When did Luminopia One receive FDA 510(k) clearance?

Luminopia One received FDA 510(k) clearance on 2022-11-04, under 510(k) number K221659.

Who is the listed applicant for Luminopia One?

The FDA 510(k) record lists Luminopia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luminopia One?

The FDA product code for Luminopia One is QQU.

Other records listing Luminopia, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243819Luminopia K233720Luminopia

Related Devices (Code: QQU)

K243819LuminopiaLuminopia, Inc.K233720LuminopiaLuminopia, Inc.K221375CureSight-CS100Novasight , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.