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heilys® safety

Light is effective. Safety is essential.

Red light is biologically active and should be used correctly. That is why we show you transparently what to look out for to use it safely.

As of: September 2026

Assessed according to IEC/EN 62471

Photobiological safety assessed using a recognised standard procedure.

No UV light

Red and near-infrared only, 630–850 nm

No lasers

Wide-area LED technology, no focused beam

Developed and tested in Germany

CE · EMC · RoHS · WEEE

Safety at a glance

You will find the most important answers right here at a glance. Further details follow further down the page.

Question Short answer
Is red and near-infrared light ionising? No. Each photon does not have enough energy to damage DNA directly — unlike UV or X-rays.
Do heilys® devices contain UV? No. UV radiation lies below about 400 nm. heilys® works exclusively in the red and near-infrared range from 630 to 850 nm.
Do I have to wear protective goggles? If the light shines towards your eyes, keep them closed or wear the safety goggles supplied. As a general rule: do not stare directly into the LEDs.
Can I overdo it? Yes. More is not better. Stick to the distance and duration given in the instructions for use.
Can the skin burn? Not when used as intended. Additional instructions apply to contact devices (FlexiPad, FaceMask).
Are there people who should not use it? Yes. With certain medical conditions, medication or special circumstances, you should refrain from use or seek medical advice beforehand. You will find the overview further down.

Basics

What “safe” actually means when it comes to light

In brief

Safety with light cannot be described with a single number. It results from five variables: wavelength, irradiance, distance, duration and light distribution. If one of them changes, the assessment changes.

Light is a biological stimulus. That is the whole reason why photobiomodulation (targeted action of light on cells) is studied at all — and at the same time the reason why it cannot be dosed arbitrarily. A stimulus that has no effect would be risk-free and ineffective. A stimulus that has an effect needs an upper limit.

That is why the question “Is red light safe?” cannot be answered as it stands. What can be answered is: Is this device safe, at this distance, for this duration, for this person? These are exactly the four factors covered on this page.

Brightness is of no help here. Near-infrared light is almost invisible to the eye and can still be working at full power. Conversely, a glaring red surface says little about the actual irradiance. What matters, therefore, are the measured values – not the impression of brightness.

Defined wavelengths

630 · 660 · 670 · 810 · 830 · 850 nm.
heilys® works exclusively with red and near-infrared light. No UV light is included. Wavelengths above 1000 nm are not used either, as they are absorbed more strongly by the water in the tissue and therefore mainly produce heat.

Measured irradiance

Stated in mW/cm² at a defined distance. Without this information, no dose can be calculated.

Recommended distance

The greater the distance from the device, the lower the irradiance. The right distance therefore helps you to dose your session safely.

Limited session duration

Irradiance × time gives the dose. Time is the second adjusting screw.

Controlled light distribution

Even illumination instead of hotspots. This prevents individual areas from being irradiated much more strongly than others.

Eye protection

Through design, distance and safety goggles. Details in the “Eyes” section.

More light does not mean more effect. The instructions for use are not just a package insert but part of the safety concept.

Tested and classified

Photobiological safety: what IEC/EN 62471 really says

In brief

IEC/EN 62471 is the standard for the photobiological safety of lamps and LED systems. It has no pass and no fail. It assigns a light source to one of four risk groups — depending on how long you can be exposed to it before a limit value is reached.

Group Meaning
Exempt group (RG 0) No photobiological risk, even with continuous exposure.
Risk group 1 No risk under normal use, as people do not usually expose themselves to the light source indefinitely.
Risk group 2 No risk as long as natural aversion responses take effect — such as closing the eyelids when dazzled.
Risk group 3 Risk even with brief exposure. Not intended for consumer products.

The classification is not a property of the device alone, but is always tied to a measuring distance. The same lamp may be classified differently at 20 cm than at 50 cm. Anyone who states a risk group without a distance is giving no usable information.

For red and near-infrared LEDs, three of the hazards assessed in the standard are particularly relevant: the retinal thermal hazard, the infrared hazard to the eye and the thermal hazard to the skin. The photochemical retinal hazard – the so-called blue light hazard – plays practically no role here. The associated weighting function, i.e. the assessment of different wavelengths according to their contribution to the blue light hazard, peaks at around 435–440 nm and drops sharply in the red range.

Photobiological hazard functions and the heilys working range Logarithmic chart of the actinic UV hazard function S(λ), peaking at 270 nanometres, and the blue light hazard function B(λ), peaking at 435 to 440 nanometres. The heilys working range of 630 to 850 nanometres lies outside both peaks; there, both functions are at about 0.001 or below. 1 0,1 0,01 0,001 0,0001 200 300 400 500 600 700 800 900 heilys® 630–850 nm 270 nm 435–440 nm S(λ) — actinic UV hazard B(λ) — blue light hazard B(λ) is defined up to 700 nm · above that, the thermal assessment applies Wavelength in nanometres (nm) relative weighting (log)
Actinic UV hazard function S(λ) and blue light hazard function B(λ) according to IEC 62471 / ICNIRP, plotted logarithmically. The heilys® working range of 630–850 nm lies outside both peaks. B(λ) is defined up to 700 nm; above that, the thermal assessments for the retina and skin apply.

Assessment by the BAuA

The German Federal Institute for Occupational Safety and Health (BAuA) has examined the photobiological safety of LEDs in a dedicated research report (baua: Report F 2115, Photobiologische Sicherheit von Licht emittierenden Dioden (LED)). Two of its statements are relevant here: LEDs are assessed according to DIN EN 62471, and in the examples examined, red LEDs showed a significantly lower photobiological risk profile than blue or white ones.

This is an assessment, not a general clearance. The report refers to general lighting, not to application devices with high irradiance at close range. The dose remains decisive.

Eye protection

Eyes: the honest answer

In brief

As a general rule: do not stare directly into the LEDs. If the light shines towards your eyes, keep them closed or wear the safety goggles supplied. In pulse mode, you should wear the safety goggles even with your eyes closed.

Red and near-infrared light is assessed differently from blue light in terms of safety, and there are biological reasons for this. Nevertheless, the rule for our devices is: do not stare into the LEDs.

There is a specific reason for this that is often underestimated: with near-infrared, the protective reflex is missing. Above about 780 nm, the human eye has practically no sensitivity. An 850 nm LED can work at full power and still appear almost dark. The glare that normally makes you look away automatically does not occur in the first place. For risk group 2, the standard relies on precisely this aversion reflex – but in the near-infrared range it cannot be relied upon.

That is why, at heilys®, the safety goggles replace what closing your eyelids does in the visible range.

LIGHT TOWARDS THE EYES

Keep your eyes closed or wear the safety goggles supplied.

PULSED LIGHT

In pulse mode, you should wear the safety goggles even with your eyes closed. The rapid light pulses can be perceived as unpleasant or straining on the nerves.

With contact lenses

There is no known risk from the lens itself. If your eyes become dry, this is more likely due to the slight warming than to the light. Taking your lenses out is the simplest solution.

After eye surgery

After LASIK, cataract surgery or other procedures, please only use the device after consulting the ophthalmologist treating you.

And what about the Vision Mode of the Gen30?

At first glance it seems contradictory: on the one hand, the recommendation is not to look directly into the LEDs. On the other hand, the Gen30 has a Vision Mode at 670 nm.

The difference lies in the dose and the controlled application.

In normal red light use, the device is aimed at areas of the body. Looking directly into the LEDs from a short distance is not intended.

With Vision Mode, it is exactly the opposite: here, the light is specifically intended for use on the eyes. That is why the parameters are clearly defined: 50 cm distance, 3 minutes’ session duration and level 2.

You will find the binding specifications in the instructions for use. Follow these specifications exactly when using Vision Mode.

When you should not use Vision Mode

  • if you have an existing retinal condition
  • after recent eye surgery
  • if you are taking photosensitising medication
  • if you have light-triggered epilepsy
  • if you have unexplained changes in vision
  • during pregnancy (due to a lack of data)
  • for children and adolescents

Skin comfort

Heat and skin

In brief

Mild warmth is normal and to be expected. Painful heat is not. The simple rule is: warm, yes; uncomfortably hot, no.

Thermal image before the session
Before the session
Thermal image after 15 minutes
After 15 minutes

When used as intended, skin temperature rises by about 2–4 °C and thus remains well below the threshold at which thermal skin damage is discussed.

Photobiomodulation is expressly not a heat-based method. The warmth you feel is a side effect, not the working principle. A strong feeling of heat is therefore not a mark of quality either, but usually a sign that the distance is too short.

Stop the session if

  • your skin feels uncomfortably hot
  • if marked redness develops or persists after the session
  • itching, tightness or burning occurs
  • you feel unwell

Contact devices: FlexiPad and FaceMask 2.0

With panels, you control the dose via the distance. With a pad or a mask, the light source sits on the skin — distance is no longer available as an adjusting screw, and the heat cannot dissipate freely. This is a different risk profile and requires different rules:

  • Do not use on irritated, injured or freshly treated skin.
  • Do not use if your temperature sensation is impaired — for example with neuropathy, after local anaesthesia or with circulatory disorders. Anyone who cannot reliably feel heat may not notice overheating in time.
  • Do not fall asleep while using it and do not cover it additionally with blankets or clothing.
  • With the FaceMask: use the eye covers and make sure the mask fits correctly.

Dosage

Can you overdo it?

In brief

Yes. Research describes a biphasic dose response: below a certain range, little or nothing is measurable; above it, the effects described may decrease again. More time or a shorter distance therefore does not automatically mean a greater effect.

More is not automatically better. If you halve the distance, the irradiance can increase roughly fourfold. If you double the session duration, the light dose doubles. But a higher dose does not automatically mean a better effect.

Change the regularity, not the duration

In research, short, regular sessions over several weeks predominate over infrequent, long ones.

DISTANCE AFFECTS THE DOSE MORE THAN YOU MIGHT THINK

If you move closer to the device, the irradiance can rise considerably – even if it does not necessarily feel stronger to you.

DO NOT COMBINE DEVICES

If you use a panel, mask and pad on the same area of the body on the same day, the total light dose can be considerably higher than intended.


Safety information

WHEN PARTICULAR CAUTION APPLIES

We distinguish between three levels here. Because it makes a difference whether there are known reasons against use, whether consulting a doctor first makes sense because robust data are lacking or the individual situation is decisive, or whether a situation is generally unproblematic and only certain instructions need to be observed. This helps you judge better when to refrain from use, when to ask your doctor first, or when you can go ahead while observing the relevant instructions.

Please do not use

Here there are known reasons against unsupervised use, or an uncertainty that leads us to advise against use as a precaution.

With active cancer

Photobiomodulation influences cell metabolism and blood flow. It has not been conclusively established scientifically how this affects tumour tissue. As long as this question remains open, restraint is the right answer. Exception only after explicit consultation with your oncologist. This applies in particular to areas of the body that are currently being irradiated as part of radiotherapy.

With light-triggered epilepsy

Devices with flashing, pulsing or changing light modes can trigger seizures. Please never use without consulting a neurologist.

On fresh surgical wounds and open wounds

Wound care with light is a medical field of application under supervision — not a topic for self-use. This also applies to acute skin infections.

With photodermatosis or severe light sensitivity

Photodermatoses lead to an unusually strong reaction to certain wavelengths of light. Which wavelengths are relevant varies depending on the condition. Examples include polymorphic light eruption, lupus erythematosus, porphyria or solar urticaria.


Consult a doctor first

Here, use is not ruled out in principle, but robust data for a reliable general recommendation are often lacking.

Red light during pregnancy and breastfeeding

We advise against it — not because a risk is known, but because robust safety data are lacking. In this situation, restraint is the only responsible recommendation.

Photosensitising medication

A number of active substances increase sensitivity to light. These include: tetracycline and quinolone antibiotics (e.g. doxycycline, ciprofloxacin), retinoids (isotretinoin, including topical), amiodarone, certain diuretics (hydrochlorothiazide), sulphonamides, some neuroleptics and antidepressants, NSAIDs such as piroxicam, and St John’s wort.

This list is not exhaustive — if in doubt, check the package leaflet or ask at the pharmacy.

Pacemakers and implanted medical devices

This applies to pacemakers, defibrillators, insulin pumps and neurostimulators. The light itself is not the issue here; it is about the electronics of the implanted medical device and local warming over the implant. Please consult the practice responsible for your care before use and do not use directly over the implant.

Red light and thyroid conditions

With an overactive thyroid (hyperthyroidism), particular caution is advised. As red and near-infrared light can influence metabolic and circulatory processes, and only very limited data are available for direct use over the thyroid, the neck area should not be irradiated in this case without consulting a doctor.

With an underactive thyroid (hypothyroidism), for example in connection with Hashimoto’s, photobiomodulation has already been studied scientifically. Possible supportive effects on cellular processes have been described.

If in doubt, use in the neck area should be clarified beforehand with a qualified medical professional.

Existing eye conditions and recent eye surgery

This also applies to unexplained changes in vision. Details in the “Eyes” section above.

Impaired sensation of temperature or pain

Do not use contact devices such as FlexiPad and FaceMask. With other devices, use with impaired sensation of temperature or pain should be discussed with a doctor beforehand.

Red light for children and adolescents

Only under adult supervision and after consulting a doctor. No specific usage data are available for children. Regardless of this, the following applies to the Vision Mode of the Gen30: do not use on children and adolescents.

After Botox, fillers and aesthetic treatments

After Botox, fillers, microneedling, peels or laser treatments, please observe the waiting period specified by the practice that treated you.

Frequently asked, generally unproblematic

Here there is generally no fundamental reason against use.

Red light and tattoos

Dark pigments absorb more light and can warm up more. Fading caused by red and near-infrared light has not been described. In practice, this means: choose a greater distance or shorten the duration if a tattooed area feels noticeably warmer than the surrounding skin. Treat fresh tattoos like a wound and leave them out until they have fully healed. The same applies to permanent make-up.

Moles and birthmarks

Red and near-infrared light is non-ionising and is not suspected of causing skin cancer — unlike UV. Anyone with many or conspicuous moles or a history of melanoma should attend regular skin cancer screening regardless. If a mole changes: see a dermatologist first, then everything else.

Retinol, fruit acids and vitamin C

These active ingredients make the skin more sensitive, but mainly to UV. If you react sensitively, use the light and the active ingredient at different times — light in the morning, active ingredient in the evening.

Pets in the room

Animals, too, usually react quite naturally to bright light and look away when it dazzles them. Nevertheless, they should not look directly into the LEDs or lie in the direct beam for long periods. Some pet owners report positive experiences with red and near-infrared light, and photobiomodulation in animals is also being studied scientifically. However, the evidence is still limited and suitable application protocols have not been consistently established. Please therefore discuss any targeted use on an animal with your vet.

Sunburn or freshly tanned skin

If you have acute sunburn, pause red light use until the skin has fully recovered.

Light quality

How it differs from UV light and lasers

No UV light

UV photons carry enough energy to break chemical bonds in DNA. As a result, UV light can cause photochemical damage to DNA and is responsible, among other things, for sunburn, premature skin ageing and an increased risk of skin cancer.

heilys® uses exclusively red and near-infrared light and contains no UV component. The devices therefore do not produce a UV tan and are not comparable to a sunbed.

No lasers

Laser light can be highly focused and can therefore concentrate high power on a very small area. That is why lasers are subject to their own safety standards and laser classes.

heilys® uses LEDs that distribute the light over a wide area. According to current understanding, this makes no difference to the cellular mechanism — but for eye safety it is a considerable difference in favour of the LED.


Device and operation

Device safety during operation

Apart from the effect of the light, there is the simple question of whether the device is safe as an electrical appliance.

Electrical safety and EMC. All heilys® devices carry the CE marking and meet the requirements of the Low Voltage and EMC Directives.

Only operate with the power supply provided. Third-party power supplies with a different voltage or output are the most common cause of defects and overheating.

Operating environment. Do not operate in damp rooms, showers or saunas unless expressly approved.

Ventilation and overheating protection. Keep ventilation openings clear and do not cover the device.

Mounting. Wall, door or stand mounting only according to the instructions and with the materials supplied. When using a stand, make sure it is stable and do not set up the device in areas where children could knock it over.

Disposal. Waste electrical equipment must not be disposed of with household waste. WEEE registration: DE19301058

Product safety

Manufacturer, responsible persons and reporting channels

Since December 2024, the General Product Safety Regulation (Regulation (EU) 2023/988) has applied in the EU. Among other things, it requires that a contact person in the EU be named for every product and that consumers be able to report safety problems directly. You will find both here.

Manufacturer / distributor
WeCare+ GmbH
Detmolder Str. 596-598
33699 Bielefeld
Germany
Phone: +49 521 759 8370
Email: hallo@heilys.de

Responsible person in the EU pursuant to Art. 16 Regulation (EU) 2023/988
Yike Pan
WeCare+ GmbH
Detmolder Str. 596-598
33699 Bielefeld
Germany
Phone: +49 521 759 8370
Email: hallo@heilys.de

Recalls and safety notices

We publish current safety notices on heilys® products on this page. There are currently none. (As of: September 2026)

Frequently asked questions

Frequently asked questions about safety

Is red light therapy dangerous?

When used as intended, no harm from red and near-infrared light has been described. It is non-ionising and each photon does not carry enough energy to damage DNA directly. Risks arise practically only from three things: looking directly into the LEDs for too long, too short a distance with the resulting warming, and use despite one of the contraindications mentioned.

Does red light therapy have side effects?

The most commonly reported are temporary skin redness and a sensation of warmth — both usually subside within a short time. Occasionally, headaches after use on the face and eye irritation after use without safety goggles are mentioned. In almost all cases, the cause is too high a dose: too close, too long or too often.

Do I need safety goggles?

As a general rule: do not stare directly into the LEDs. If the light shines towards your eyes, keep them closed or wear the safety goggles supplied. In pulse mode, you should wear the safety goggles even with your eyes closed.

Can red light burn the skin?

When used as intended, the skin should feel warm but not uncomfortably hot. In our measurement, skin temperature rose by about 2–4 °C. Particular caution applies to contact devices, to impaired temperature sensation and when the heat cannot dissipate sufficiently.

Can I use red light during pregnancy?

We advise against it – not because a risk is known, but because robust safety data are lacking. If you are nevertheless considering use, please consult a doctor beforehand.

Is red light safe with thyroid conditions?

That depends on the thyroid condition. With an overactive thyroid, the neck area should not be irradiated without consulting a doctor. With an underactive thyroid, for example in connection with Hashimoto’s, photobiomodulation has already been studied scientifically; however, the evidence is still limited. Direct use in the neck area should therefore be discussed with a doctor beforehand.

Does red light affect tattoos?

Fading has not been described. However, dark pigments absorb more light and can warm up noticeably more. If a tattooed area feels significantly warmer: increase the distance or shorten the duration. Leave out fresh tattoos until they have healed.

Is red light like a sunbed?

No. A sunbed works with UV radiation, which can cause DNA damage and tanning, among other things. heilys® uses exclusively red and near-infrared light and contains no UV component. The devices therefore do not produce a UV tan and are not comparable to a sunbed.

Can I use too much red light?

Yes. Research describes a biphasic dose-response relationship — above a certain range, the effects described decrease again. If you want more, increase the regularity, not the duration, and do not combine several devices on the same area of the body.

Are heilys® devices medical devices?

No. heilys® products are not medical devices within the meaning of Regulation (EU) 2017/745 and are not intended to detect, treat, alleviate or prevent diseases. Accordingly, we make no claims on this page about any medical or therapeutic benefit — it deals exclusively with safe use.

What does the risk group according to IEC 62471 mean?

It describes how long you can be exposed to a light source before a limit value is reached — always in relation to a defined distance. The standard has no pass or fail, but four groups.

What should I do if something happened during use?

Please report it to us — even in the case of minor incidents. Contact: hallo@heilys.de or +49 521 759 837 18. We follow up on every report.


If you are unsure, it is better to ask

You don’t have to decide on the basis of a product page alone whether red light is suitable for you. If you have a pre-existing condition, take medication or are unsure whether any of the safety instructions mentioned apply to you, please consult a doctor before use.

If you have questions about operation or would like to know which heilys® device is right for you, we will be happy to advise you by phone, by email or in our showroom in Bielefeld.

We will also tell you openly if we don’t think a heilys® device is the right choice for your situation.

Advice

Beate Schmidt · +49 521 759 837 18 · hallo@heilys.de · Mon–Fri 8:00–18:00

Bielefeld showroom

Book an appointment and try out the devices for yourself.

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This page serves solely to provide information on the safe use of heilys® products. It makes no claims about any medical or therapeutic benefit. It does not constitute medical advice and does not replace diagnosis or treatment by medical professionals.

heilys® products are not medical devices within the meaning of Regulation (EU) 2017/745 and are not intended to detect, treat, alleviate or prevent diseases.

The tests and evidence mentioned on this page relate to the safety and conformity of the devices. They do not constitute evidence of any health or therapeutic benefit. The groups of people and usage situations mentioned are safety notes, not areas of application.

If you have any existing medical conditions, are pregnant, are taking photosensitising medication or are unsure about use, please consult your doctor before using the device.

In all cases, the instructions for use supplied with the product are authoritative.