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Dr. Dennis Gross DRx SpectraLite FaceWare Pro
The only mask here running five wavelengths, and the only one whose advertised FDA clearance could not be traced to a public record. It publishes irradiance — but in the manual, not where buyers look.
This device has not been measured yet. Nothing on this page is presented as a measurement, and no irradiance figure here has been verified by us.
Specification
- Wavelengths415 nm · 605 nm · 630 nm · 660 nm · 880 nm
- LED count160
- Claimed irradiance75 mW/cm²
- Measured irradianceNot yet measured (queued)
- Session length3 minutes
- Session dose13.5 J/cm² (from claim — unverified)
- CoverageFull face, rigid moulded shell with eye cut-outs; silicone head strap only
- RegulatoryClearance advertised; no matching record found
- CE markingCE medical device · MDR CE mark shown in the international manual, with EU Authorised Representative Obelis s.a., Brussels — a standard and credible EU compliance structure.
- Warranty12 months
- Price$455
Origin
No manufacturing location could be established for the Dr. Dennis Gross DRx SpectraLite FaceWare Pro. No FDA establishment registration was found for this device under any name we searched, so no manufacturing location can be established from public records. Source: FDA Establishment Registration & Device Listing database.
What the regulatory status actually means
No FDA clearance was located for Dr. Dennis Gross DRx SpectraLite FaceWare Pro.
Last verified