Home / 510(k) Clearances / K212947

510(k) K212947

Trinity Plus Wrinkle Reducer by Carol Cole Company Dba Nuface — Product Code OHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2022
Date Received
September 15, 2021
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 Carol Cole Company Dba Nuface

  • K201906 — Trinity ELE Plus and Trinity ELE Plus Pro (February 24, 2021)
  • K201782 — NuFace Trinity Plus Device (January 22, 2021)
  • K191672 — NuFACE Mini Device (October 15, 2019)
  • K182424 — NuFACE FIX Skin Toning Device (December 18, 2018)
  • K181008 — NuFACE Trinity (October 11, 2018)
  • K171588 — NuBODY Skin Toning Device (July 31, 2017)

Other clearances for product code OHS

  • 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)
  • K253135 — LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1 (December 23, 2025)
  • K253054 — LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) (December 19, 2025)