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FDA 510(k)

Visibly Digital Acuity Product

K-Number: K220090 · 2022-08-12

ApplicantVisibly, Inc.
Decision Date2022-08-12
Product CodeQTO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Visibly Digital Acuity Product is the device name listed in this FDA 510(k) record. The listed applicant is Visibly, Inc.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K220090. The device is classified under product code QTO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visibly Digital Acuity Product?

Visibly Digital Acuity Product is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Visibly, Inc.. The 510(k) number is K220090.

When did Visibly Digital Acuity Product receive FDA 510(k) clearance?

Visibly Digital Acuity Product received FDA 510(k) clearance on 2022-08-12, under 510(k) number K220090.

Who is the listed applicant for Visibly Digital Acuity Product?

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

What is the FDA product code for Visibly Digital Acuity Product?

The FDA product code for Visibly Digital Acuity Product is QTO.

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.