NuYOU360 Ventures LLC Publishes Four-Question Standard for Evaluating At-Home Light Therapy Devices

Arlington, Virginia

The at-home light therapy category has expanded rapidly, with dozens of brands now selling face masks and related devices directly to consumers. But product pages across the category vary widely in what they disclose. Some list wavelengths precisely; others describe only "red light" or "near-infrared." Output figures appear with no indication of how or where they were measured. Regulatory language is used loosely, with terms that carry very different legal meanings presented as interchangeable.

The four questions NuYOU360 published are these. What are the exact wavelengths, in nanometers? What is the irradiance, and at what measurement position was it taken? Is the device cleared by the FDA with a clearance number that can be verified, or only registered? And how is the emitter count defined?

The company says the second question is the one most consumers do not know to ask. Irradiance, expressed in milliwatts per square centimeter, describes the power density of light reaching a surface. Measured at the surface of an emitter under ideal laboratory conditions, the figure can be several times higher than the output that reaches a user's face while the device is worn. Both numbers may be technically accurate. Only one describes the treatment.

The fourth question addresses a similar ambiguity. Many devices across the category are built on shared hardware platforms, and emitter counts can be stated in more than one way depending on whether individual emitters or multi-emitter chips are being counted. A dramatically higher advertised count does not necessarily indicate different hardware.

NuYOU360 has answered all four questions for each product it sells. Its Contour PRO, priced at $594, uses 72 quad-chip VCSEL emitters, which the company also states as 288 individual emitters so the figure cannot be inflated by choosing the more flattering number. The device operates at 460nm, 665nm, 850nm and 1064nm, and is rated up to 100mW/cm² at the VCSEL zone. It is registered with the FDA, with a 510(k) submission in progress.

The company's RADIANCE, priced at $369, uses 400 LEDs across five wavelengths at 415nm, 590nm, 625nm, 830nm and 1072nm, delivering up to 50mW/cm² measured at the worn position rather than at the emitter. It holds FDA clearance under K242385. NuYOU360's entry device, priced at $289, is cleared under the same number.

NuYOU360 was founded by Dora Tzotchevska, who used light therapy devices daily for nearly a decade before launching the company. That experience, she has said, is what convinced her that the barrier facing most buyers is not price or skepticism but the simple inability to compare.

The full standard, with guidance on how to apply each question to any device on the market, is published on the company's website.

Boardroom Release. A press release supplied by NuYOU360 Ventures LLC and published as issued on The Storefront. Claims are those of the company.