Methodology

How the Institute evaluates a device, and how we grade the evidence behind a therapy.

Device certification

When a manufacturer submits a device, our assessment follows a fixed sequence so that every product is held to the same standard:

1. Fit-for-purpose design review. We examine whether the device’s optics, geometry and intended use are coherent with its therapeutic claim.
2. Wavelength & irradiance verification. We measure the emitted wavelength(s) and energy output (irradiance, mW/cm²) and compare them against accepted metrics in the field and against the dose ranges supported by published studies.
3. Safety & dosing audit. We review instructions, treatment durations, power supply and built-in safeguards, including any ocular-exposure limits, against recognised photobiological safety guidance.
4. Independent tester outcomes. We engage testers to use the device per the provided instructions over the indicated period, and review their experience and outcomes against the intended results.

A device that meets or exceeds our thresholds on all measures may receive certification. One that does not, does not, and we tell the manufacturer why.

How we grade the evidence in reviews

Our written reviews assign two labels. The first is a plain-language evidence verdict; the second is a strength-of-evidence grade describing the quality of the underlying studies.

Evidence verdicts

Verdict	What it means
Likely helpful	Consistent benefit across multiple controlled studies, with effect sizes that are clinically meaningful.
Promising	Early controlled trials are positive, but the body of evidence is still small or short-term.
Mixed	Studies conflict, or benefit appears in some endpoints but not others.
Emerging	Mostly preclinical or pilot data; too early to judge clinical benefit.
Insufficient evidence	No adequately controlled human data, or evidence of no benefit.

Strength-of-evidence grades

Adapted from standard evidence hierarchies: High (multiple consistent randomised controlled trials or systematic reviews), Moderate (one or more RCTs with limitations), Low (controlled observational or small pilot studies), Very low (case series, animal or in-vitro work only).