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510(k) K242977

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) by Xuzhou Kernel Medical Equipment Co., Ltd. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2025
Date Received
September 26, 2024
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.

  • K222751 — LED Light Therapy Device, KN-7000L (February 1, 2023)
  • K200971 — 308nm Excimer System (December 15, 2020)
  • K200929 — Hair Growth System (June 3, 2020)
  • K190685 — Hair Growth System (July 26, 2019)
  • K181805 — UV Phototherapy (January 11, 2019)
  • K160341 — Colposcope System (September 14, 2016)
  • K132643 — UV PHOTOTHERAPY (January 30, 2014)

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)
  • 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)
  • K210004 — i8 Tanning Booth (December 10, 2021)