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FDA 510(k)

Enhanced AURORA™ Medical Diode System, and related accessories

K-Number: K230076 · 2023-03-08

ApplicantPsoria-Shield, Inc.
Decision Date2023-03-08
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Enhanced AURORA™ Medical Diode System, and related accessories is a medical device manufactured by Psoria-Shield, Inc.. It received FDA 510(k) clearance on 2023-03-08 under approval number K230076. 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 Enhanced AURORA™ Medical Diode System, and related accessories?

Enhanced AURORA™ Medical Diode System, and related accessories is a medical device that received FDA 510(k) clearance on 2023-03-08. It is manufactured by Psoria-Shield, Inc.. The 510(k) number is K230076.

When was Enhanced AURORA™ Medical Diode System, and related accessories approved by the FDA?

Enhanced AURORA™ Medical Diode System, and related accessories received FDA 510(k) clearance on 2023-03-08, under approval number K230076.

What company makes Enhanced AURORA™ Medical Diode System, and related accessories?

Enhanced AURORA™ Medical Diode System, and related accessories is manufactured by Psoria-Shield, Inc..

What is the FDA product code for Enhanced AURORA™ Medical Diode System, and related accessories?

The FDA product code for Enhanced AURORA™ Medical Diode System, and related accessories is FTC.

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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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