Irradiance Levels and CE certification of our RLF Panels

Irradiance Levels and CE certification of our RLF Panels – the big subjects!

Quick History:

The Directors of Dermfix have been manufacturing EU medical phototherapy devices incorporating UVB light since 2009, with EU, CE, MDSAP approval and we have extensive expertise in light-based Class IIa products and also ISO13485 certification.  Our products have sold around the world with approval by TÜV SÜD in Germany, MHRA in the UK, TGA in Australia and Health Canada.

Our new 2025 range of red-light panels have been designed and manufactured for Dermfix GmbH to our exacting standards, but these wavelengths of light (unlike UVB) do not require full Class IIa Medical Device MDD certification so fortunately this keeps our device approval and production costs lower, and in turn our prices to you lower.

CE Certification:

These products do require EN60335-2-27:2014 certification for sale in Europe because they “incorporate IR emitters” that emit electromagnetic energy at wavelengths above 780nm.  This is all detailed in EN60335-2-27: 2014 which is the international standard for “Particular requirements for appliances for skin exposure to optical radiation”.

We are sadly aware of many competitors without the correct CE documentation.  Just ask them if they have EN60335-2-27 certification!

Note: Under EU law if a company sells under their own name or brand, they are considered the manufacturer, so are responsible for product safety testing and compliance.

Irradiance Levels:

We have many customers asking for precise mW/cm2 output levels to “compare” to competitors.  Regretfully there are some very misleading claims for output of these devices, with competitors using dubious and cheap solar meters to back up unrealistic figures.  Solar meters such as the Solarmeter Model 9.6, Tenmars TM-206, TES1333 have all been used to try and prove unrealistic figures.

For in-house testing we use a Hopoocolor OHSP350IR which is close to industry standard, but for more accurate testing we also rely on 3rd party approved EU laboratories with high-quality calibrated medical grade spectrometers (although these test results are only produced and available for our internal Technical Files due to business confidentiality).

Another complication with irradiance output figures is that due to the way light spreads, scatters and combines you will always get the highest output figure when at the very centre of a device.  This output figure will drop as you move away from the centre, towards the sides or the top and bottom.  It is not a fault, but just the way that light naturally operates.

As can be seen from the screenshot below our devices typically provide a peak output of around 100 mW/cm2 at the very centre at 15cm (on 100% settings), but for treatment calculations it is better to estimate an overall output of around 80 mW/cm2 for the larger panels (and perhaps 60 mW/cm2 on smaller panels).  Whilst this sounds at first a little inaccurate, once you have worked with a spectrometer you can see how much outputs vary at different points on light emitting devices.

We would therefore like to make some relevant points:

If you read in our Red-Light Q&A section you can see it would be very difficult to overdose on red light therapy.  So, a slightly longer treatment time will generally be well-tolerated with no side-effects.

80 mW/cm2 average is a very strong output and more than adequate for most users and treatment protocols.  These lights are bright and powerful.

To achieve the correct Joules of treatment it is generally better for your skin/body not to use excessive power outputs, but to have a slightly longer gradual and regular exposure.

If competitors claim unrealistic output figures such as 150+ mW/cm2 with no supporting documentation or screenshots be wary!