Aura Storm
FDA 510(k) K212644 · Invictus Lighting
510(k) numberK212644
Submission
- Device name
- Aura Storm
- Applicant
- Invictus Lighting
Hickory, NC, US - Received
- August 20, 2021
- Decision date
- May 26, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRA – Purifier, Air, Ultraviolet, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6500
- Specialty
- General Hospital
Other 510(k)s with product code FRA
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|---|---|---|---|
| K252128 | Zener® (model ZEN-001-B1)FRA · Traditional | Uvx, Inc. | 09/15/2025SE |
| K241140 | ViroZap Indoor Air Purifier, In Duct Model 1008FRA · Traditional | Applied Photonix, LLC | 08/01/2024SE |
| K232642 | AirKEE T900FRA · Traditional | Healkee Medical Pte, Ltd. | 05/23/2024SE |
| K232933 | AirKEE P900FRA · Traditional | Healkee Medical Pte, Ltd. | 05/16/2024SE |
| K232645 | Airgle Room Air PurifierFRA · Traditional | Airgle Corporation | 02/16/2024SE |
| K221540 | Synexis Sphere RxFRA · Traditional | Synexis, LLC | 06/14/2023SE |
| K222702 | RGS; RGS MiniFRA · Traditional | Genesis Air, Inc. | 06/02/2023SE |
| K223328 | PurgoFRA · Special | Aeroclean Technologies, Inc. | 11/30/2022SE |
| K213753 | PurgoFRA · Traditional | Aeroclean Technologies, LLC | 06/01/2022SE |
| K212824 | Bluezone Model RX-450 Air PurifierFRA · Traditional | Bluezone Products, Inc. | 02/17/2022SE |
Questions and answers
When was Aura Storm cleared by the FDA?
Aura Storm (K212644) received a 510(k) decision of Substantially Equivalent on May 26, 2022, 279 days after the submission was received.
What is the product code of K212644?
The FDA product code is FRA – Purifier, Air, Ultraviolet, Medical, a Class II (moderate risk) device regulated under 21 CFR 880.6500.