TRUDERMAL Pro (ZLD-390)

The TRUDERMAL Pro (ZLD-390) is an over-the-counter LED light therapy device that emits three specific wavelengths—blue (415nm), red (630nm), and near-infrared (850nm)—for dermatological and musculoskeletal treatment. It reduces full-face wrinkles, treats mild-to-moderate inflammatory acne, and provides topical heating to relieve minor muscle/joint pain, stiffness, and arthritis symptoms. The device consists of a flexible silicone LED panel, controller, power adapter, base seats, and eye protectors for facial and body use.

The subject device delivers LED light at wavelengths of 415nm (blue), 630nm (red), and 850nm (infrared) with irradiances ranging from 6–20 mW/cm² and radiation doses of 7.2–24 J/cm² depending on the wavelength combination. Treatment time is 20 minutes per session, 3–4 times weekly. The device uses a standard AC/DC power adapter (100–240V input) and LED irradiance source. Wavelengths, irradiances, and radiation doses are similar to predicate devices K212275 and K221775, though some predicate devices show different irradiance values.

Electrical safety and electromagnetic compatibility: IEC 60601-1 (Edition 3.2), IEC 60601-1-11 (Edition 2.1), IEC 60601-2-57 (Edition 2.0), IEC 60601-1-2 (Edition 4.1), IEC TS 60601-4-2 (2024), and IEC 62471 (2006). Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23. Software verification and validation conducted per FDA Guidance for Software in Medical Devices.

The device is substantially equivalent because it shares the same indications for use, working principle, classification (Class II, product codes OHS/OLP/ILY), and regulatory framework (21 CFR 878.4810) as four legally marketed predicates. The wavelengths (415, 630, 850nm) and treatment parameters (irradiance, dose, duration) are clinically similar to predicates, with minor variations that do not raise new safety or effectiveness questions. Non-clinical testing (electrical safety, biocompatibility, software validation) demonstrates conformance to the same voluntary design standards as the predicates. Component materials are identical in formulation and geometry to previously cleared devices, eliminating new biocompatibility concerns. The submitter provided no clinical testing, relying instead on substantial equivalence of design, function, and performance characteristics to established predicate devices.