K192411 is an FDA 510(k) clearance for the Psoria-Shield AURORA. This device is classified as a Light, Ultraviolet, Dermatological (Class II - Special Controls, product code FTC).
Submitted by Psoria-Shield (Utica, US). The FDA issued a Cleared decision on July 2, 2020, 302 days after receiving the submission on September 4, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K192411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2019 |
| Decision Date | July 02, 2020 |
| Days to Decision | 302 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTC - Light, Ultraviolet, Dermatological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4630 |