Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ, Uvb Narrow Band 50HZ, Uvb Narrow Band 60HZ

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K022104 ↗

FDA Product Code

FTC

Device Class

Class II

Regulation

21 CFR Part 878.4630

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 3 Series Phototherapy Cabinet

  Class II

  FDA 510(k) K042502 Active Cleared 14 Oct 2004

• Smart Touch Uvtherapy Multiple Machine

  Class II

  FDA 510(k) K110912 Active Cleared 20 Oct 2011

• 3 Series NeoLux

  Class II

  FDA 510(k) K230382 Active Cleared 24 Mar 2023

• DT Controlled Phototherapy Equipment

  Class II

  FDA 510(k) K233811 Active Cleared 13 Dec 2023

• 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 Open recall

  Class II

  FDA 510(k) K100378 Active Cleared 28 Apr 2010

• Dermapal with Digital Timer

  Class II

  FDA 510(k) K073587 Active Cleared 18 Jan 2008

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