Certification Report: Spectral Wavefront Device (Kyper Spectral Science Inc.)

Subject device: Spectral Wavefront optical device, Kyper Spectral Science Inc.
Mandate: Effectiveness and Safety, January 2025.

Scope of review

The Institute of Optical Therapeutics studied and reviewed the Spectral Wavefront optical device, investigated its design for fit-for-purpose, reviewed a patent application, and considered the appropriateness of its instructions and safety guidelines.

What we assessed

The Institute investigated the light wavelength(s) and energy output of the device versus accepted metrics in the field, and examined the instructions, design and safeguards built into the device and its power supply.

Findings

• Safety: The device meets or exceeds our safety standards on all measures assessed, including wavelength, energy output, instructions and power-supply safeguards.
• Effectiveness: The Institute engaged testers to use and explore the device per the provided instructions over the indicated time periods. We reviewed testers’ experience and outcomes against the intended outcomes, and found the device to be effective.

Conclusion

On the basis of this review, the Spectral Wavefront device met the Institute’s thresholds for both safety and effectiveness within the scope and protocol assessed.