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510(k) K260150

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) by NOOANCE — Product Code OHS

K260150 is an FDA 510(k) premarket notification submitted by NOOANCE for the device "LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)". The FDA issued a decision of Substantially Equivalent on April 22, 2026. 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
April 22, 2026
Date Received
January 20, 2026
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

  • K261407 — XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPR (July 15, 2026)
  • K261473 — Chromix (July 1, 2026)
  • K261052 — LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) (June 29, 2026)
  • 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)
  • 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)

FDA data resources