Trinity Plus Wrinkle Reducer
FDA 510(k) K212947 · Carol Cole Company Dba Nuface
510(k) numberK212947
Submission
- Device name
- Trinity Plus Wrinkle Reducer
- Applicant
- Carol Cole Company Dba Nuface
Vista, CA, US - Received
- September 15, 2021
- Decision date
- April 2, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OHS – Light Based Over The Counter Wrinkle Reduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
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|---|---|---|---|
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…OHS · Traditional | Kam Yuen Plastic Products , Ltd. | 08/31/2026SE |
| K261602 | Eye Recovery Pro (PH-e03)OHS · Traditional | Shenzhen Goodwind Technology Development Co., Ltd. | 08/10/2026SE |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)OHS · Traditional | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 08/07/2026SE |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…OHS · Traditional | Shenzhen Qianyu Technology Co., Ltd. | 08/04/2026SE |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756)OHS · Traditional | Duplex International Trading Limited | 08/04/2026SE |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038)OHS · Traditional | Led Intellectual Properties, LLC | 07/31/2026SE |
| K260598 | 5 Wavelength LED Facemask (TN2508)OHS · Traditional | iSMART Developments, Ltd. | 07/24/2026SE |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…OHS · Traditional | Dongguan Miqiang Technology Co., Ltd. | 07/15/2026SE |
| K261473 | ChromixOHS · Traditional | Termosalud S.L. | 07/01/2026SE |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)OHS · Traditional | Guangdong Newdermo Biotech Co., Ltd. | 06/29/2026SE |
More from Guangdong Newdermo Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K240564 | NuFACE® FIX+NFO · Traditional | 06/27/2024SE |
| K201906 | Trinity ELE Plus and Trinity ELE Plus ProNFO · Traditional | 02/24/2021SE |
| K201782 | NuFace Trinity Plus DeviceNFO · Traditional | 01/22/2021SE |
| K191672 | NuFACE Mini DeviceNFO · Traditional | 10/15/2019SE |
| K182424 | NuFACE FIX Skin Toning DeviceNFO · Traditional | 12/18/2018SE |
| K181008 | NuFACE TrinityNFO · Traditional | 10/11/2018SE |
| K171588 | NuBODY Skin Toning DeviceNFO · Traditional | 07/31/2017SE |
Questions and answers
When was Trinity Plus Wrinkle Reducer cleared by the FDA?
Trinity Plus Wrinkle Reducer (K212947) received a 510(k) decision of Substantially Equivalent on April 2, 2022, 199 days after the submission was received.
What is the product code of K212947?
The FDA product code is OHS – Light Based Over The Counter Wrinkle Reduction, a Class II (moderate risk) device regulated under 21 CFR 878.4810.