The following data is part of a premarket notification filed by Psoria-shield with the FDA for Psoria-shield Aurora.
| Device ID | K192411 |
| 510k Number | K192411 |
| Device Name: | Psoria-Shield AURORA |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Psoria-Shield 409 Mandeville St Utica, NY 13502 |
| Contact | John Yorke |
| Correspondent | John Yorke Psoria-Shield 409 Mandeville St Utica, NY 13502 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B780AUR20000 | K192411 | 000 |