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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 a medical device manufactured by Visibly, Inc.. It received FDA 510(k) clearance on 2022-08-12 under approval 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. It is manufactured by Visibly, Inc.. The 510(k) number is K220090.

When was Visibly Digital Acuity Product approved by the FDA?

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

What company makes Visibly Digital Acuity Product?

Visibly Digital Acuity Product is manufactured by Visibly, Inc..

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

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

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Related PubMed Literature

PMID: 40469887 Postmarket Safety Surveillance of FDA-Cleared Prescription Digital Therapeutics Using the Manufacturer and User Facility Device Experience (MAUDE) Database: A Pharmacovigilance Study. Cureus (2025) PMID: 40424619 Digital Therapeutics in China: Comprehensive Review. Journal of medical Internet research (2025) PMID: 40395709 Decoding FDA Labeling of Prescription Digital Therapeutics: A Cross-Sectional Regulatory Study. Cureus (2025) PMID: 40380731 Effective Requirements Engineering in Early-Stage Digital Health Startups. Studies in health technology and informatics (2025)

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.

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