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Psoria-Shield AURORA

by Psoria-Shield

510(k) K192411

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK192411 Date2 Jul 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FTC
Device Class
Class II
Regulation
21 CFR Part 878.4630
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Psoria-Shield Aurora is a dermatological ultraviolet light device designed for targeted phototherapy. It emits specific wavelengths of ultraviolet light to treat skin conditions such as psoriasis, leveraging controlled exposure to promote therapeutic effects on affected areas.

This device is supplied as a reusable medical diode system and is classified as a Class II moderate-risk device under FDA regulations. It is intended for use in clinical settings, including dermatology offices and specialized phototherapy centers, and requires proper handling and maintenance as outlined in its instructions. The device’s regulatory status includes FDA 510(k) clearance (K192411) under the Special 510(k) pathway for General, Plastic Surgery applications.

Other devices from Psoria-Shield Inc

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of skin conditions is the Psoria-Shield Aurora specifically designed to treat?

    The Psoria-Shield Aurora is designed for targeted phototherapy to treat psoriasis, a chronic skin condition characterized by red, scaly patches. Its ultraviolet light emissions are tailored to promote therapeutic effects on affected areas, though its primary indication is explicitly psoriasis as described in the device’s regulatory submission.

  • Is the Psoria-Shield Aurora a single-use or reusable device, and what maintenance does it require?

    The Psoria-Shield Aurora is a reusable medical diode system, meaning it is intended for repeated use in clinical settings like dermatology offices or phototherapy centers. Proper handling and maintenance—including cleaning and calibration—are required as outlined in the device’s instructions to ensure safety and efficacy.

  • How is the Psoria-Shield Aurora regulated, and what does its FDA clearance under the Special 510(k) pathway mean for clinicians?

    The Psoria-Shield Aurora holds FDA 510(k) clearance (K192411) under the Special 510(k) pathway for General, Plastic Surgery applications. This classification means the device has been determined *substantially equivalent* to a legally marketed predicate, confirming its safety and performance for dermatological ultraviolet light therapy as intended. Clinicians may rely on this clearance as evidence of regulatory review.

  • What settings or environments is the Psoria-Shield Aurora intended for, and does it require specialized training?

    The device is intended for use in clinical settings, such as dermatology offices or specialized phototherapy centers. While the regulatory submission does not explicitly mention training requirements, its classification as a Class II moderate-risk device implies that proper training on operation, safety protocols, and patient monitoring is advisable to ensure correct usage and mitigate risks.