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510(k) K153749

3 Series Phototherapy Unit by Daavlin Distributing Company — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2016
Date Received
December 29, 2015
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

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Other clearances for product code FTC

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  • 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)
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  • K220840 — 1 Series Phototherapy Equipment (April 22, 2022)