Home / 510(k) Clearances / K192411

510(k) K192411

Psoria-Shield AURORA by Psoria-Shield — Product Code FTC

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

Other clearances by Psoria-Shield

  • K230076 — Enhanced AURORA™ Medical Diode System, and related accessories (March 8, 2023)
  • K103540 — PSORIA-LIGHT (February 10, 2011)

Other clearances for product code FTC

  • K253871 — Klär Lite (RCW-KL1000) (March 4, 2026)
  • K250425 — Ultraviolet Phototherapy Device (April 7, 2025)
  • K244022 — 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm (March 13, 2025)
  • K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-50 (February 6, 2025)
  • K242908 — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, (December 19, 2024)
  • K233811 — DT Controlled Phototherapy Equipment (December 13, 2023)
  • K223882 — Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) (March 27, 2023)
  • K230382 — 3 Series NeoLux (March 24, 2023)
  • K230076 — Enhanced AURORA™ Medical Diode System, and related accessories (March 8, 2023)
  • K220840 — 1 Series Phototherapy Equipment (April 22, 2022)