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510(k) K233811

DT Controlled Phototherapy Equipment by Daavlin Distributing Co. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2023
Date Received
November 29, 2023
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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  • K182215 — ClearLink Controlled Phototherapy Equipment (October 29, 2018)
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  • 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

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  • K242908 — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, (December 19, 2024)
  • 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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