Home / 510(k) Clearances / K260946

510(k) K260946

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) by Guangdong Newdermo Biotech Co., Ltd. — Product Code OHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
March 23, 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 by Guangdong Newdermo Biotech Co., Ltd.

  • K260202 — LED Light Therapy Masks (LumiLips FAC07NA) (March 23, 2026)
  • K223544 — LED light therapy mask (FM-01, FM-02, FM-03) (February 23, 2023)

Other clearances for product code OHS

  • 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)
  • K254079 — LED Light Therapy Mask (Models: T2, RLD10) (March 16, 2026)
  • K260511 — Ulike Reglow Light Therapy Device (UM10) (March 16, 2026)
  • K253874 — LED Therapy Light (COB1400, HP1800PRO) (March 3, 2026)
  • K253683 — FAQ™ (LED Panel); FAQ™ (Dual LED Panel) (February 20, 2026)
  • K254007 — LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) (February 12, 2026)