# K251012: TRUDERMAL Pro (ZLD-390)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Aug 14, 2025 after 134 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 188 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212275: Dermalux Flex MD, Aesthetic Technology, Ltd. (2021) Summary page 6.
- K223544: LED light therapy mask (FM-01, FM-02, FM-03), Guangdong Newdermo Biotech Co., Ltd. (2023) Summary page 6.
- K242789: Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006), Dongguan Laiguang Electronic Technology Co., Ltd. (2025) Summary page 6.
- K221775: LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003), Light Tree Ventures Europe B.V. (2022) Summary page 6.

## Most influential descendants
- K260946: LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) (2026), 0 descendants of its own

## Indications for use
TRUDERMAL Pro (Model: ZLD-390) is an over-the-counter(OTC) device that delivering targeted phototherapy using three wavelengths(blue:415nm, red:630nm, Infrared(IR):850nm): Red light: Reduces full-face wrinkles. Blue light: Treats mild to moderate inflammatory acne. IR light: Provides topical heating for the purpose of elevating tissue temperature, temporarily relieving minor muscle and joint pain, arthritis and muscle spasms; relieving stiffness; promoting relaxation of muscle tissues and temporarily increasing local blood circulation. Mixed lights: Red+IR light: Reduces full-face wrinkles. Blue+Red light:Treats mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K251012
Methodology: https://510kreport.com/methodology