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510(k) K132643

UV PHOTOTHERAPY by Xuzhou Kernel Medical Equipment Co., Ltd. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2014
Date Received
August 26, 2013
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 Xuzhou Kernel Medical Equipment Co., Ltd.

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Other clearances for product code FTC

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