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FDA 510(k)

Luminopia

K-Number: K233720 · 2024-08-08

Decision Date2024-08-08
Product CodeQQU
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Luminopia is the device name listed in this FDA 510(k) record. The listed applicant is Luminopia, Inc.. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K233720. 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 2024-08-08. The listed applicant is Luminopia, Inc.. The 510(k) number is K233720.

When did Luminopia receive FDA 510(k) clearance?

Luminopia received FDA 510(k) clearance on 2024-08-08, under 510(k) number K233720.

Who is the listed applicant for Luminopia?

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?

The FDA product code for Luminopia 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.

Related Devices (Code: QQU)

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.

Official Source

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