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FDA 510(k)

Psoria-Shield AURORA

K-Number: K192411 · 2020-07-02

ApplicantPsoria-Shield
Decision Date2020-07-02
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Psoria-Shield AURORA is the device name listed in this FDA 510(k) record. The listed applicant is Psoria-Shield. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K192411. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Psoria-Shield AURORA?

Psoria-Shield AURORA is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Psoria-Shield. The 510(k) number is K192411.

When did Psoria-Shield AURORA receive FDA 510(k) clearance?

Psoria-Shield AURORA received FDA 510(k) clearance on 2020-07-02, under 510(k) number K192411.

Who is the listed applicant for Psoria-Shield AURORA?

The FDA 510(k) record lists Psoria-Shield as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Psoria-Shield AURORA?

The FDA product code for Psoria-Shield AURORA is FTC.

Other records listing Psoria-Shield 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.

K230076Enhanced AURORA™ Medical Diode System, and related accessories

Related Devices (Code: FTC)

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.

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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.

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