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510(k) K182215

ClearLink Controlled Phototherapy Equipment by Daavlin Distributing Company — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2018
Date Received
August 15, 2018
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

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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)
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  • K230382 — 3 Series NeoLux (March 24, 2023)
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  • K220840 — 1 Series Phototherapy Equipment (April 22, 2022)