Data / Medical devices / United States / Psoria-Shield Inc
Psoria-Shield Inc: FDA-registered device maker in Utica, NY, United States, 2 510(k) clearances
Psoria-Shield Inc is registered with the FDA (registration 3008872264) in Utica, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 8, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008872264
- Address
- 409 Mandeville St, Utica, NY, United States, 13502
- Owner or operator
- Psoria-Shield Inc (10035602)
- Roles
- Manufacturer
- First device listed
- August 4, 2020
- Registered through
- 2026
- Brand names listed
- AURORA TM, Enhanced AURORA Medical Diode System, and related accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light, Ultraviolet, Dermatological | FTC | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 8, 2023 | K230076 | Enhanced AURORA Medical Diode System, and related accessories | FTC | Substantially Equivalent | Psoria-Shield, Inc. | accessdata.fda.gov |
| July 2, 2020 | K192411 | Psoria-Shield AURORA | FTC | Substantially Equivalent | Psoria-Shield | accessdata.fda.gov |
Compare with other makers
Updated March 8, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.