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510(k) K260202

LED Light Therapy Masks (LumiLips FAC07NA) by Guangdong Newdermo Biotech Co., Ltd. — Product Code OHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2026
Date Received
January 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.

  • K223544 — LED light therapy mask (FM-01, FM-02, FM-03) (February 23, 2023)

Other clearances for product code OHS

  • 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)
  • K253833 — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD0 (January 30, 2026)
  • K252603 — HIGHERDOSE Body Sculptor (Model: GS-03) (January 28, 2026)
  • K253712 — LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, (January 23, 2026)
  • K253400 — LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X (December 24, 2025)
  • K253279 — Feather/numiere 05 06 07 (05) (December 24, 2025)