Aura Storm— 510(k) K212644

Substantially Equivalent

Invictus Lighting

FDA 510(k) clearance K212644 for Aura Storm, Substantially Equivalent on 2022-05-26. Applicant: Invictus Lighting. Device class: 2.

Clearance details

Applicant: Invictus Lighting
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2021-08-20
Decision date: 2022-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hickory, NC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.