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510(k) K230076

Enhanced AURORA™ Medical Diode System, and related accessories by Psoria-Shield, Inc. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2023
Date Received
January 10, 2023
Clearance Type
Traditional
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

Other clearances by Psoria-Shield, Inc.

  • K192411 — Psoria-Shield AURORA (July 2, 2020)
  • K103540 — PSORIA-LIGHT (February 10, 2011)

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