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510(k) K223882

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) by Shenzhen Honpal Optoelectronic Technology Co., Ltd. — Product Code FTC

K223882 is an FDA 510(k) premarket notification submitted by Shenzhen Honpal Optoelectronic Technology Co., Ltd. for the device "Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)". The FDA issued a decision of Substantially Equivalent on March 27, 2023. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2023
Date Received
December 27, 2022
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 for product code FTC

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  • 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)
  • 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)
  • 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)

FDA data resources