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510(k) K212510

7 Series Phototherapy Device by Daavlin Distributing Co. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2021
Date Received
August 10, 2021
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 Daavlin Distributing Co.

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  • K230382 — 3 Series NeoLux (March 24, 2023)
  • K220840 — 1 Series Phototherapy Equipment (April 22, 2022)
  • K210881 — M Series Phototherapy Equipment (June 22, 2021)
  • K182215 — ClearLink Controlled Phototherapy Equipment (October 29, 2018)
  • K153749 — 3 Series Phototherapy Unit (June 30, 2016)
  • K151795 — ML24000 UVA-1 Phototherapy Cabinet (September 10, 2015)
  • K110912 — SMART TOUCH UVTHERAPY MULTIPLE MACHINE (October 20, 2011)
  • K111172 — 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES (August 29, 2011)
  • K103708 — ML24000 UVA-1 PHOTOTHERAPY UNIT (February 22, 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)