Ulike Reglow Light Therapy Device (UM10)
FDA 510(k) K260511 · Shenzhen Ulike Smart Electronics Co., Ltd.
510(k) numberK260511
Submission
- Device name
- Ulike Reglow Light Therapy Device (UM10)
- Applicant
- Shenzhen Ulike Smart Electronics Co., Ltd.
Shenzhen, CN - Received
- February 17, 2026
- Decision date
- March 16, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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 |
|---|---|---|
| K261325 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…OHT · Special | 05/21/2026SE |
| K260742 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…OHT · Traditional | 05/05/2026SE |
| K252804 | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR…OHT · Special | 10/01/2025SE |
| K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)OHS · Traditional | 10/01/2025SE |
| K251984 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…OHT · Special | 07/24/2025SE |
| K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…OHT · Traditional | 07/11/2025SE |
| K250938 | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01…OHT · Traditional | 05/23/2025SE |
| K243749 | Jmoon Conductive GelGYB · Traditional | 04/08/2025SE |
| K250194 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)OHT · Traditional | 03/26/2025SE |
| K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)NFO · Traditional | 02/03/2025SE |
Questions and answers
When was Ulike Reglow Light Therapy Device (UM10) cleared by the FDA?
Ulike Reglow Light Therapy Device (UM10) (K260511) received a 510(k) decision of Substantially Equivalent on March 16, 2026, 27 days after the submission was received.
What is the product code of K260511?
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.