510(k) K192411
K192411 is an FDA 510(k) premarket notification submitted by Psoria-Shield for the device "Psoria-Shield AURORA". The FDA issued a decision of Substantially Equivalent on July 2, 2020. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Psoria-Shield has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2020
- Date Received
- September 4, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Ultraviolet, Dermatological
- Device Class
- Class II
- Regulation Number
- 878.4630
- Review Panel
- SU
- Submission Type