Enhanced AURORA Medical Diode System, and related accessories
FDA 510(k) K230076 · Psoria-Shield, Inc.
510(k) numberK230076
Submission
- Device name
- Enhanced AURORA Medical Diode System, and related accessories
- Applicant
- Psoria-Shield, Inc.
Utica, NY, US - Received
- January 10, 2023
- Decision date
- March 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Enhanced AURORA Medical Diode System, and related accessories cleared by the FDA?
Enhanced AURORA Medical Diode System, and related accessories (K230076) received a 510(k) decision of Substantially Equivalent on March 8, 2023, 57 days after the submission was received.
What is the product code of K230076?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.