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510(k) K252189

LED Light Therapy Mask (2311, 2344, 2457, 2458) by Dongguan Yanxi Technology Co., Ltd. — Product Code OHS

K252189 is an FDA 510(k) premarket notification submitted by Dongguan Yanxi Technology Co., Ltd. for the device "LED Light Therapy Mask (2311, 2344, 2457, 2458)". The FDA issued a decision of Substantially Equivalent on September 12, 2025. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2025
Date Received
July 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over The Counter Wrinkle Reduction
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.

Other clearances for product code OHS

  • K260946 — LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) (June 18, 2026)
  • K254025 — LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) (June 16, 2026)
  • K260715 — CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (June 3, 2026)
  • K260415 — myLEDmask 2 (MJ-144) (May 12, 2026)
  • K260150 — LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) (April 22, 2026)
  • K260202 — LED Light Therapy Masks (LumiLips FAC07NA) (March 23, 2026)
  • K260511 — Ulike Reglow Light Therapy Device (UM10) (March 16, 2026)
  • K254079 — LED Light Therapy Mask (Models: T2, RLD10) (March 16, 2026)
  • K253874 — LED Therapy Light (COB1400, HP1800PRO) (March 3, 2026)
  • K253683 — FAQ™ (LED Panel); FAQ™ (Dual LED Panel) (February 20, 2026)

FDA data resources