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heilys® Safety

Light is effective. Safety is critical.

Red light is not a harmless feel-good product, nor is it a risk that should be concealed. This page states precisely what has been tested, what values apply to your device, and when you should consult a doctor beforehand.

Evaluated according to IEC/EN 62471

Risk groups specified per device — reports available for download

No UV Light

Exclusively red and near-infrared, 630–850 nm

No Lasers

Flat LED technology, no concentrated beam

Developed and tested in Germany

CE · EMC · RoHS · WEEE

Safety at a Glance

Most visitors want exactly these six lines. Everything else is below.

Question Short Answer
Is red and near-infrared light ionizing? No. It does not have enough energy per photon to directly damage DNA — unlike UV or X-ray radiation.
Do heilys® devices contain UV? No. The spectral range is 630–850 nm.
Do I need to wear safety glasses? Yes, for full-body and facial applications. The exact specifications per device are listed in the table below.
Can I overdo it? Yes. More is not better. Adhere to the distance and duration specified in the instructions for use.
Can the skin burn? Not with proper use. For contact devices (FlexiPad, FaceMask), additional instructions apply.
Are there people who should not use it? Yes. The complete list is below — please read it if any of the situations apply to you.

Fundamentals

What "safe" even means for light

In Short

Light safety cannot be described by a single number. It results from five parameters: wavelength, irradiance, distance, duration, and light distribution. If one of these changes, the assessment changes.

Light is a biological stimulus. This is the whole reason why photobiomodulation is studied at all — and also 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 like that. What can be answered is: Is this device, at this distance, for this duration, safe for this person? These exact four conditions are on this page.

Brightness does not help here. Near-infrared light is almost invisible to the eye and can still operate at full power. Conversely, a glaring red surface says little about the actual irradiance. What counts is measured — not perceived.

Defined Wavelengths

630 · 660 · 670 · 810 · 830 · 850 nm. No UV, no component above 1000 nm, where water absorption primarily generates heat.

Measured Irradiance

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

Recommended Distance

Irradiance drops rapidly with distance. Distance is the most effective safety parameter you can control.

Limited Session Duration

Irradiance × time equals dose. Time is the second adjustment knob.

Controlled Light Distribution

Uniform illumination instead of hotspots. Uneven light means that partial areas receive significantly more than planned.

Eye Protection

By design, distance, and protective eyewear. Details in the "Eyes" section.

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

Tested and Classified

Photobiological Safety: What IEC/EN 62471 Really States

In Short

IEC/EN 62471 is the standard for the photobiological safety of lamps and LED systems. It knows no passing or failing. It assigns a light source to one of four risk groups — depending on how long one 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 with normal, behaviorally limited exposure.
Risk Group 2 No risk as long as natural aversion reactions occur — such as blinking due to glare.
Risk Group 3 Risk even with short-term exposure. Not intended for consumer products.

The classification is not a property of the device alone, but is always tied to a measurement distance. The same luminaire can be classified differently at 20 cm than at 50 cm. Anyone who states a risk group without a distance does not provide usable information.

For red and near-infrared LEDs, three of the hazards evaluated in the standard are particularly relevant: thermal retinal hazard, infrared ocular hazard, and thermal skin hazard. The photochemical retinal hazard — the so-called blue light hazard — plays practically no role here, because the associated weighting function has its maximum at about 435–440 nm and drops sharply in the red region.

Photobiologische Gefährdungsfunktionen und der heilys-Arbeitsbereich Logarithmisches Diagramm der aktinischen UV-Gefährdungsfunktion S(λ) mit Maximum bei 270 Nanometern und der Blaulicht-Gefährdungsfunktion B(λ) mit Maximum bei 435 bis 440 Nanometern. Der heilys-Arbeitsbereich von 630 bis 850 Nanometern liegt außerhalb beider Maxima; dort liegen beide Funktionen bei etwa 0,001 oder darunter. 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) — aktinische UV-Gefährdung B(λ) — Blaulicht-Gefährdung B(λ) ist bis 700 nm definiert · darüber gilt die thermische Bewertung Wellenlänge in Nanometer (nm) relative Gewichtung (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 is outside both maxima. B(λ) is defined up to 700 nm; above that, the thermal assessments for retina and skin apply.

Classification according to BAuA

The German Federal Institute for Occupational Safety and Health (BAuA) investigated the photobiological safety of LEDs in its own research report (baua: Report F 2115, Photobiological Safety of Light Emitting Diodes (LED)). Two statements from it are relevant here: LEDs are evaluated according to DIN EN 62471, and in the examined examples, red LEDs showed a significantly lower photobiological risk profile than blue or white ones.

This is a classification, not an approval. The report refers to general lighting, not to application devices with high irradiance at close range. The dose remains crucial.

Specific Values

Your Values: Safety Data per Device

In Short

Safety is dose-dependent, and the dose depends on the device. A panel at 30 cm distance, a mask directly on the face, and a pad on the skin have three different risk profiles. Therefore, here are the values individually.

Device Risk Group
IEC/EN 62471
Recommended Distance Max. Session Duration Safety Glasses Irradiance
Gen 300
Panel
Testing in progress Testing in progress Testing in progress Testing in progress Testing in progress
Gen 70
Panel
Testing in progress Testing in progress Testing in progress Testing in progress Testing in progress
Gen 30 + Vision
Compact Panel
Testing in progress Testing in progress Testing in progress Testing in progress Testing in progress
FaceMask 2.0
Contact Application
Testing in progress Contact Application Testing in progress Testing in progress Testing in progress
FlexiPad
Contact Application
Testing in progress Contact Application Testing in progress not required Testing in progress

All values are from [test lab / measurement report], measured with [measuring device] under [measurement conditions]. The complete test reports can be found in the download area below.

Eye Protection

Eyes: The Honest Answer

In Short

Basic rule: Do not look directly into the LEDs during operation. For full-body and facial applications, wear the provided safety glasses. For targeted eye application with Gen 30 + Vision, specific, stricter guidelines apply — these are listed below.

Red and near-infrared light are evaluated differently in terms of safety than blue light, and this is also biologically justified. Nevertheless, for our panels: do not look into them.

There is a specific reason for this that is often underestimated. With near-infrared, the protective reflex is absent. The human eye has practically no sensitivity above about 780 nm. An 850 nm LED can operate at full power and still appear almost dark. The glare reflex, which normally makes you automatically look away, does not even occur. The standard relies precisely on this aversion reflex for risk group 2 — in the near-infrared range, one cannot rely on it.

Therefore, with heilys®, the safety glasses replace what blinking achieves in the visible range.

For Panel Application

Put on safety glasses, even if you are sitting to the side. Reflections from bright walls or mirrors are regularly underestimated.

For Facial Application

Keep eyes closed and additionally wear safety glasses, unless the instructions for use of your device state otherwise.

For Contact Lenses

No risk from the lens itself is known. If eyes become dry, this is more due to slight warming than to light. Removing lenses is the simplest solution.

After Eye Surgeries

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

And what about the Vision mode of the Gen 30?

This question belongs on a safety page because otherwise it looks like a contradiction: We say "do not look into the LEDs," and the Gen 30 has a Vision mode with 670 nm.

The difference lies not in the light, but in dose and control.

For panel application, the device is directed at body surfaces. A casual glance into the LEDs from a short distance is an exposure that no one planned and no one counts. This is exactly what the safety glasses are meant to prevent.

The Vision mode, conversely, works exclusively with fixed parameters: defined wavelength, defined distance, defined and short duration, defined frequency. It is only intended within these specifications. [Insert protocol: distance, duration, frequency, eyes open or closed, irradiance at the eye.]

The binding values are in the instructions for use. If the application deviates from these, it is no longer covered by our specifications.

When you should not use Vision Mode

  • with existing retinal disease
  • after recent eye surgeries
  • when taking photosensitizing medications
  • with light-triggered epilepsy
  • with unexplained vision changes
  • during pregnancy (due to lack of data)
  • for children and adolescents

Skin Comfort

Heat and Skin

In short

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

Thermal image before treatment
Before treatment
Thermal image after 15 minutes
After 15 minutes

Measurement: [device, distance, room temperature, camera model, number of subjects]. Skin temperature rises by about 2–4 °C with proper use, remaining well below the threshold at which thermal skin damage is discussed.

Photobiomodulation is expressly not a heat treatment. The warmth you feel is a side effect, not a principle of action. A strong sensation of heat is therefore not a quality feature, but usually an indication of insufficient distance.

Stop the application if

  • the skin feels unpleasantly hot
  • redness exceeds the usual level or persists after application
  • itching, tightness, or burning occurs
  • you feel unwell

Contact devices: FlexiPad and FaceMask 2.0

For panels, you regulate the dose via distance. With a pad or mask, the light source lies on the skin—distance is eliminated as an adjustment screw, and heat cannot dissipate freely. This presents a different risk profile and requires different rules:

  • Do not apply to irritated, broken, or freshly treated skin.
  • Do not use if temperature sensation is impaired—e.g., with neuropathy, after local anesthesia, or with circulatory disorders. Those who cannot reliably feel heat may not notice overheating in time.
  • Do not fall asleep with it on and do not cover it additionally with blankets or clothing.
  • Do not use over the thyroid gland without medical consultation.
  • For the FaceMask: Eye openings must be correctly positioned. If the mask slips, please reposition it rather than continuing to wear it.

Dosage

Can you do too much?

In short

Yes. Research on photobiomodulation describes a biphasic dose-response relationship: below a certain range, nothing is measurable, and above it, the described effects decrease again. More time or less distance does not automatically mean more.

This is the most uncomfortable finding in the field for advertising, which is why it's here: A device can be used too intensely. Halving the distance approximately quadruples the irradiance. Doubling the time doubles the dose. Neither automatically leads to more, but possibly beyond the optimum.

Change regularity, not duration

In research, short, regular applications over several weeks dominate over infrequent, long ones.

Distance is more important than sensation

It changes the dose more than time—and you won't notice it.

Do not stack multiple devices

Panel plus mask plus pad on the same region in one day is a dose that no one has calculated.

Safety Instructions

Who should be cautious

We categorize this into three levels, instead of concluding a list with a blanket "consult your doctor." The distinction between "there is a known reason for this" and "reliable data is lacking" is important for your decision—and we believe it's a distinction that should be named.

Please do not use

Here, there is either a known reason or a risk that we cannot assess.

In case of active cancer

Photobiomodulation influences cell metabolism and blood circulation. It is not conclusively scientifically clarified how this affects tumor tissue. As long as this question remains open, caution is the right answer. Exceptions only after explicit oncological consultation. This applies particularly within the radiation field of ongoing therapy.

In case of light-triggered epilepsy

Devices with flashing, pulsating, or changing light modes can trigger seizures. Please do not use without neurological consultation.

On fresh surgical wounds and open wounds

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

In case of photodermatosis or severe light sensitivity

Such as polymorphic light eruption, lupus erythematosus, porphyria, or solar urticaria.

Clarify with a doctor beforehand

Not forbidden, but a decision that should not be made on a product page.

Red light during pregnancy and breastfeeding

We advise against it—not because a risk is known, but because reliable safety data is lacking. In this situation, caution is the only serious recommendation. Particularly, no application in the abdominal and pelvic areas.

Photosensitizing medications

A number of active ingredients increase light sensitivity. These include, among others: tetracycline and quinolone antibiotics (e.g., doxycycline, ciprofloxacin), retinoids (isotretinoin, also topical), amiodarone, certain diuretics (hydrochlorothiazide), sulfonamides, some neuroleptics and antidepressants, NSAIDs like piroxicam, and St. John's wort.

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

Pacemakers and implanted medical devices

This affects pacemakers, defibrillators, insulin pumps, and neurostimulators. The light itself is not the issue here; it's about the device's electronics and local heating above the implant. Please clarify with your treating physician before use and do not apply directly over the implant.

Red light for thyroid conditions

One of the most frequently asked questions. Reliable data on the use over the thyroid gland with home devices is not available—neither for a risk nor for harmlessness. For thyroid conditions, nodules, or ongoing medication, we recommend avoiding the neck area or clarifying with a doctor beforehand.

Existing eye diseases and recent eye surgeries

Also for unexplained vision changes. Details in the "Eyes" section above—especially regarding the Vision Mode of Gen 30.

Impaired temperature or pain sensation

Such as diabetic neuropathy, circulatory disorders, or after local anesthesia. Particularly relevant for contact devices, as heat cannot dissipate freely there.

Red light for children and adolescents

Only under adult supervision and after medical consultation. No specific application data for children is available.

After Botox, fillers, and aesthetic treatments

After Botox, fillers, microneedling, chemical peels, or laser treatments, please observe the waiting period specified by your treating physician.

Frequently asked, generally unproblematic

The questions we receive most often—with an honest answer instead of a blanket warning.

Red light and tattoos

Dark pigments absorb more light and can heat up more. Fading due to red and near-infrared light has not been described. Practically, this means: choose a greater distance or shorten the duration if a tattooed area feels significantly warmer than the surrounding skin. Treat fresh tattoos like a wound and avoid them until they are completely healed. The same applies to permanent make-up.

Moles and birthmarks

Red and near-infrared light is non-ionizing and is not suspected of causing skin cancer—unlike UV. Anyone with many or noticeable moles or a history of melanoma should undergo regular skin cancer screening regardless. If a mole changes: first consult a dermatologist, then proceed further.

Retinol, fruit acids, and vitamin C

These active ingredients make the skin more sensitive, but primarily to UV. If you react sensitively, apply light and active ingredients separately—light in the morning, active ingredient in the evening.

Pets in the room

Dogs and cats should not be able to look directly into the LEDs and should not be constantly in the direct beam path. For application to animals, there are specific devices and specialists—please clarify with a veterinarian, do not improvise.

Sunburn or freshly tanned skin

In case of acute sunburn, pause until the skin has healed.

Light Quality

No UV, no lasers

No UV light

UV photons carry enough energy to break chemical bonds in DNA. This causes sunburn, accelerated skin aging, and UV-related skin cancer risk. The actinic UV hazard peaks at approximately 270 nm.

heilys® operates between 630 and 850 nm—the devices contain no UV components. heilys® is not designed to simulate sun exposure and does not replace a solarium, as it has nothing to do with one.

No lasers

Laser light is coherent and highly concentrated; the entire power can fall on a single point. Therefore, it is evaluated according to its own standards and classified into laser classes.

heilys® uses LEDs that distribute light over an area. For the cellular mechanism, this is currently understood to be irrelevant—for eye safety, it is a significant difference in favor of LED.

Device and Operation

Device safety in operation

Besides the effect of light, there's the simple question of whether the device is safe as an electrical appliance.

Electrical safety and EMC. All heilys® devices bear the CE mark and meet the requirements of the Low Voltage and EMC Directives. [Add test standards and test laboratory]

Operate only with the supplied power adapter. Third-party power adapters with differing voltage or power are the most common cause of defects and overheating.

Operating environment. Do not operate in damp rooms, showers, or saunas unless expressly approved. Protection class: [IP class per device]

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

Installation. Wall, door, or stand mounting only according to instructions and with the supplied materials. For stand mounting, ensure stable positioning and do not place the device in areas where children can knock it over.

Disposal. Waste electrical and electronic equipment does not belong in household waste. WEEE registration: [WEEE Reg. No.]

Product Safety

Manufacturer, Responsible Parties, and Reporting Channels

Since December 2024, the Product Safety Regulation (Regulation (EU) 2023/988) applies in the EU. Among other things, it requires that a contact person in the EU be designated for every product and that consumers can directly report safety issues. You can find both here.

Manufacturer / Distributor
[full company name, address, email, phone]

Responsible Person in the EU according to Art. 16 Regulation (EU) 2023/988
[Name, address, contact – if identical to the manufacturer, state this explicitly]

Recalls and Safety Notices

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

Evidence

Tests and Evidence

We deliberately distinguish between two things that are often mixed in advertising: normative tests, which are legally required or normatively defined — and voluntary tests, which we commissioned ourselves.

Test / Standard What it covers Evidence
CE Conformity with applicable EU directives Declaration of Conformity
IEC/EN 62471 Photobiological safety, classification into risk groups Test report per device
EMC Directive Electromagnetic compatibility Test report
Low Voltage Directive Electrical safety Test report
RoHS Restriction of hazardous substances Declaration
WEEE Take-back and disposal of waste electrical and electronic equipment Registration number

Frequently Asked Questions

Frequently Asked Questions about Safety

Is red light therapy dangerous?

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

Does red light therapy have side effects?

The most commonly reported side effects are temporary skin redness and a feeling of warmth — both usually subside within a short time. Headaches after facial applications and eye irritation after use without protective eyewear are occasionally reported. In almost all cases, the cause is too high a dose: too close, too long, or too frequent.

Do I need protective eyewear?

Yes, when using panels. The reason is less the red light than the near-infrared light: it is almost invisible to the eye, which is why the glare reflex that would otherwise automatically make you look away is absent. The protective eyewear takes over this function. It is not necessary for contact devices on the body.

Can red light burn the skin?

Not at the intended distance and duration. The skin temperature increases by about 2–4 °C in our measurements. There is a higher risk with contact devices, with severely impaired temperature sensation, and if the device is covered.

Can I use red light during pregnancy?

We advise against it. Not because a risk is known, but because reliable safety data is lacking. If you still consider using it, please clarify with your gynecologist beforehand and always avoid the abdominal and pelvic areas.

Is red light safe for thyroid conditions?

There is no reliable data on this — in either direction. We therefore recommend avoiding the neck area or clarifying the application with a doctor beforehand. There are no restrictions for all other body regions.

Does red light affect tattoos?

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

Is red light like a tanning bed?

No, and the difference is mechanistic, not gradual. A tanning bed uses UV radiation, which can cause DNA damage and triggers tanning. heilys® contains no UV components. The two have nothing in common except the word "lamp."

Can I use too much red light?

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

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 diagnose, treat, alleviate, or prevent diseases. Accordingly, we make no statement on this page about any health effects — it deals exclusively with safe use.

What does the risk group according to IEC 62471 mean?

It describes how long one can be exposed to a light source before a limit value is reached — always in relation to a defined distance. The standard does not have a pass or fail, but four groups. The classification of your device can be found in the table above, the complete test report in the download section.

What do I do if something happened during use?

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

If you are unsure, it's better to ask

Red light is not a decision that needs to be made based on a product page. If you have a pre-existing condition, are taking medication, or are simply unsure which device is right for you: call us, write to us, or visit us in our showroom in Bielefeld and try it out.

We will also tell you if we think a heilys® device is not suitable for your situation.

Consultation

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

Showroom Bielefeld

Book an appointment and try out the devices yourself.