TRUDERMAL Pro (ZLD-390)
FDA 510(k) K251012 · Shenzhen Kaiyan Medical Equipment Co., Ltd.
510(k) numberK251012
Submission
- Device name
- TRUDERMAL Pro (ZLD-390)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
Shenzhen, CN - Received
- April 2, 2025
- Decision date
- August 14, 2025
- 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.
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 |
|---|---|---|
| K253932 | FACEGYM Pro Device (HD-109)NFO · Traditional | 07/23/2026SE |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)OHS · Traditional | 06/16/2026SE |
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)OLI · Traditional | 05/04/2026SE |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )OLI · Traditional | 04/15/2026SE |
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)OLP · Traditional | 03/04/2026SE |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03)OHS · Traditional | 01/28/2026SE |
| K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)OAP · Traditional | 01/23/2026SE |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP · Traditional | 10/30/2025SE |
| K252272 | ORA Method LED Gua Sha (GS-04)OHS · Traditional | 10/09/2025SE |
| K251781 | Kala Mini 2.0 (KALA-04)OHS · Traditional | 09/04/2025SE |
Questions and answers
When was TRUDERMAL Pro (ZLD-390) cleared by the FDA?
TRUDERMAL Pro (ZLD-390) (K251012) received a 510(k) decision of Substantially Equivalent on August 14, 2025, 134 days after the submission was received.
What is the product code of K251012?
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.