Supervision of beauty care and solarium services  

For all equipment, the following information about the equipment is requested:  

• the intended use of the equipment   
• instructions for use of the device and any additional instructions for carrying out the treatments   
• model or brand name of the device   
• manufacturer of the device   
• importer of the device, if known   
• explanation of how it has been ensured that the treatments are safe   
• list of contraindications to treatments. 

For laser devices, the following information on the device is requested:  

• laser safety class of the device   
• wavelength of the laser radiation   
• size of the laser beam on the skin (spot size). 

For devices that emit continuous laser radiation, the following is also requested:   

• output power or fluence. 

For devices emitting pulsed laser radiation, the following is also requested:   

• pulse energy, energy or power density (fluence) or output power   
• pulse width (pulse duration). 

For RF devices, the following information on the device is requested:  

• RF radiation frequency   
• shape of the electrodes on the treatment heads and the size of the area they delimit or the volume of tissue into which the RF energy is applied. 

For devices that emit continuous RF radiation:  

• output RF power, energy, power density or energy density. 

For devices emitting pulsed RF radiation:   

• pulse energy, energy density, power density or output RF power   
• pulse width (pulse duration). 

For ultrasound equipment, the following information on the device is requested:   

 One of the following:   

1. the ultrasonic intensity (ISATA) and peak intensity (ISPTA) or the RBN or BNR value (beam non-uniformity ratio)  
2. ultrasonic power and effective radiating area (beam area)   
3. ultrasonic pulse energy, pulse width, pulse duration and effective radiating area (beam area). 

For ultrasound focusing devices (e.g. HIFU), the following is also requested: 

1. spot size in the focal point   
2. number of focal points if several points are exposed simultaneously. 

For intense pulsed light (IPL) devices, the following information on the device is requested:  

• pulse energy or fluence  
• pulse width (pulse duration)   
• aperture size (spot size). 

The exposure limit sets the maximum amount of radiation that can be applied to a customer's body during a beauty care treatment. The limit value is not always a single number and may instead depend on the characteristics of the radiation itself. The first step is for the provider to find out the applicable exposure limit value for his equipment. The limit values for the different types of equipment are described in more detail in the contents of the menu below.  

The next step is to determine the exposure caused by the use of the equipment and, if necessary, to convert it into the unit corresponding to the unit of the exposure limit value. The exposure may be given in the technical data of the equipment or it may be calculated on the basis of the technical specifications of a device. The exposure caused by the use of the device should then simply be compared with the exposure limit value. Should the exposure remain below the limit value, the use of the device in beauty care services is allowed.  

In most cases, exceeding the exposure limit value in beauty care services is not permitted. The content of the menu below describes the exceptions to this rule in which the use of exposures above the limit value is allowed. The menu also contains information on the possibility of demonstrating the safety of a procedure when the limit value is exceeded.  

The purpose of the exposure limit values is to protect the safety of customers of beauty care services. However, it is also in the interest of the service provider to use devices not exceeding the limits, thus ensuring the safety of the treatments as far as use of radiation goes. Continuing the use of devices that exceed the exposure limits is not always possible or may require significant changes to the business operations, such as obtaining a license to provide private healthcare services. If there is no acceptable justification for continuing to use a device that is too powerful, the financial loss of the equipment purchase often has to be borne by the service provider. 

In the case of laser devices, the laser safety class of the device already gives a fairly strong indication as to whether the device can be used in beauty care services. The laser class should be marked on every laser device. Lasers used in beauty care services must not be Class 4 lasers. Using Class 4 lasers for the treatment of the skin requires a license to provide private healthcare services.  

Class 1C and Class 3B laser equipment must be assessed on a case-by-case basis. Class 1C lasers only work in contact with the skin, but may contain a Class 4 laser source, in which case the skin exposure and therefore the risks associated with their use are similar to those of a Class 4 laser.  

Section 5 of STUK regulation S/11/2021 lays down the conditions under which lasers with a power of up to 500 milliwatt (mW) may be used in beauty care services. This includes Class 3B lasers producing continuous laser radiation. However, in the case of Class 3B lasers that produce very short pulses, the service provider must ensure that the limit values for skin exposure to laser radiation laid down in Annex 2 to Decree 1045/2018 of the Ministry of Social Affairs and Health are not exceeded.  

The STUK regulation also allows the use of laser equipment that complies with the requirements of SFS-EN 60335-2-113, even if the exposure from the use of the equipment exceeds the limit values. This is based on the fact that the standard lays down requirements for the radiation safety of the equipment.

Radiofrequency (RF) radiation is a type of radiation that targets large amounts of electromagnetic energy directly to the skin and subcutaneous tissues, creating a risk of burns. The absorption of RF radiation into the skin and subcutaneous tissues varies according to factors such as skin conductivity, the surface area and shape of the treatment head and the frequency used. More energy than intended may be absorbed by the skin, resulting in stinging and redness or burns in the worst case. Some of the damage may occur beneath the surface layer of the skin.  

The RF energy applied to the body causes a warming effect. The magnitude of this effect is assessed by the local specific absorption rate (SAR). Section 6 of STUK regulation S/11/2021 lays down the RF exposure limits for beauty care services. The exposure limits are 10 W/kg (watts per kilogram) for the head and body and 20 W/kg for limbs. Unfortunately, the exposure caused by the device is not usually indicated as a SAR in the instructions, so it has to be calculated or estimated on a case-by-case basis.  

Exceeding the limit values of the STUK regulation during the treatments is not allowed. In some cases, a treatment device exceeding the limits of the regulation can be brought into compliance by drafting additional instructions on how to perform the treatments. If the device cannot be made safe to use despite the additional instructions, it will be banned from further use.  

The standard EN 60335-2-115 on beauty care appliances sets practically equivalent radiation safety requirements for cosmetic radiofrequency treatment devices as the STUK regulation S/11/2021. The use of devices that meet the requirements of this standard is therefore permitted in beauty care services.  

The intensity and frequency of ultrasound vary greatly depending on the type of treatment. Ultrasound can damage blood vessels and the nervous system and cause inflammation and bleeding in tissues.  

In high intensity focused ultrasound (HIFU) devices, a large amount of energy is focused into a small volume, increasing the risk for subcutaneous tissue damage.  

Ultrasound cavitation carries risks, particularly for the safety of the fetus. High-intensity ultrasound radiation can reach the fetus endangering its health and development. The Ministry of Social Affairs and Health and STUK consider that ultrasound cavitation should not be performed on pregnant women under any circumstances.  

However, ultrasound devices used for skin cleansing (ultrasound spatulas) are probably safe to use.  

Section 7 of STUK regulation S/11/2021 sets limits for ultrasound intensity, thermal index and mechanical index. According to the regulation, the ultrasound intensity must not exceed 3 W/cm² (watts per square centimetre) or the ultrasound thermal index must be less than 1,0 and the mechanical index less than 0,7. The spatial-peak intensity must not exceed 24 W/cm². The exposure limit values for the eye are stricter and the application of ultrasound energy to the eye should be avoided.  

Ultrasound devices are subject to a transitional period lasting until 15 December 2023, during which the use of devices exceeding the limit values is still permitted, provided that the use of ultrasound does not pose a health risk. STUK recommends that the exposure limit values should already be complied with during the transitional period if there are any doubts about the safety of the treatment.  

The standard EN 60335-2-115 on beauty care equipment sets practically equivalent radiation requirements for cosmetic ultrasound equipment as STUK regulation S/11/2021. The use of equipment that meets the requirements of this standard is therefore permitted in beauty care services.

Intense pulsed light (IPL) devices produce a short pulse of light on the skin. According to Annex 2 of Decree 1045/2018 of the Ministry of Social Affairs and Health, the skin exposure limit value is determined by the equation H = 20 000 t^0,25 J/m², where t is the duration of the light pulse in seconds. The exposure of IPL devices is often expressed in joules per square centimeter (J/cm2) in which case the equation H = 2 t^0,25 J/cm² can be used instead. For example, for a light pulse with a duration of 1 millisecond (0,001 second), the limit value is H = 0,36 J/cm².  

STUK estimates that all IPL devices currently in use exceed the exposure limit values. A transitional period until 15.12.2023 applies to IPL devices, during which the use of devices exceeding the limit values is still permitted, provided that their use does not pose a health risk.  

Section 5 of STUK regulation S/11/2021 also allows the use of IPL devices that meet the requirements of SFS-EN 60335-2-113, even if the exposure from the use of the device exceeds the limit values. This is because the standard lays down requirements for the radiation safety of the devices.  

 In the marketing of IPL devices, other abbreviations such as SHR, ILS or E-light are sometimes used. However, the devices are based at least in part on the use of light pulses and are therefore subject to the same exposure limits. 

In beauty care, ultraviolet (UV) radiation is mainly used for nail polish curing. UV radiation is subject to exposure limit values laid down in the Decree 1045/2018 of the Ministry of Social Affairs and Health and in Annex 2 of the Decree.  

STUK's market surveillance measurements conducted on nail polish dryers did not reveal any devices exceeding the limit values. Although there is no safe lower limit for UV radiation per se, the UV exposure from nail polish dryers is so low that their occasional use is unlikely to have adverse effects. If desired, the backs of the hands can be protected with sunscreen or with gloves that leave just the fingertips bare. 

In nail polish dryers with replaceable lamps, only lamps specified by the manufacturer as suitable replacement lamp for the device should be used. It may be possible to fit some appliances with, for example, a germicidal UV lamp, which can burn the skin after only a short exposure time.

The use of exposure above the exposure limit values in cosmetic treatment may be allowed if the safety of the treatment can be reliably demonstrated. The equipment manufacturer, who has the best knowledge of the technical characteristics of the equipment and of other factors affecting radiation safety, is best placed to provide such a demonstration.  

Demonstrations of safety are evaluated on a case-by-case basis and there are no predefined requirements for their content. However, the content of the demonstration should describe how it has been ensured that exposure exceeding the limit values will not cause unintended tissue damage or other adverse effects. The level of detail required of the contents of the demonstration also depend on the extent to which the limit values are exceeded.  

In all cases, a demonstration of the safety of the procedure cannot be made in practice. For example, skin treatment with a Class 4 laser is considered to be such a demanding procedure that it can only be performed in a healthcare unit. In this case the company providing the service must apply for a license to provide private healthcare services from the Regional State Administrative Agency (AVI) or the National Supervisory Authority for Welfare and Health (Valvira).