FAQ (LED Panel); FAQ (Dual LED Panel)
FDA 510(k) K253683 · Foreo, Inc.
510(k) numberK253683
Submission
- Device name
- FAQ (LED Panel); FAQ (Dual LED Panel)
- Applicant
- Foreo, Inc.
Las Vegas, NV, US - Received
- November 21, 2025
- Decision date
- February 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
Other 510(k)s with product code OHS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K242747 | Faq (302)OAP · Traditional | 12/11/2024SE |
| K241102 | Luna 4 plusOHS · Traditional | 08/20/2024SE |
| K240616 | Faq (102)PAY · Traditional | 07/15/2024SE |
| K232242 | BEAR 2 BodyNFO · Traditional | 05/13/2024SE |
| K240378 | Faq 201, Faq 202OHS · Traditional | 04/19/2024SE |
| K231977 | PEACH 2, PEACH 2 Duo, PEACH 2 goOHT · Traditional | 09/25/2023SE |
| K222012 | Faq 101PAY · Traditional | 04/05/2023SE |
| K200803 | BEAR and BEAR miniNFO · Traditional | 07/31/2020SE |
| K162450 | ESPADA Acne-Clearing Blue Light PenOLP · Traditional | 11/30/2016SE |
Questions and answers
When was FAQ (LED Panel); FAQ (Dual LED Panel) cleared by the FDA?
FAQ (LED Panel); FAQ (Dual LED Panel) (K253683) received a 510(k) decision of Substantially Equivalent on February 20, 2026, 91 days after the submission was received.
What is the product code of K253683?
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.