(Art. 5, 7 para. 2 and 9 para. 2)
The following treatments may only be carried out by persons with a certificate of competence in accordance with Article 5 paragraph 1 letter c or by physicians in accordance with Article 5 paragraph 1 letter a or by their practice personnel in accordance with Article 5 paragraph 1 letter b:
1.1 Treatment of:
1.2 Removal of:
a. hair;
b. permanent make-up by laser treatment, subject to the requirements of Number 2.2;
c. tattoos by laser treatment, subject to the requirements of Number 2.2.
1.3 Laser acupuncture.
2.1 Only physicians qualified in accordance with Article 5 paragraph 1 letter a, or their practice personnel in accordance with Article 5 paragraph 1 letter b, may carry out the following treatments:
m sebaceous gland hyperplasia;
n. varicose and spider veins;
o. vitiligo;
p. warts;
q. xanthelasma.
2.2 Only physicians qualified in accordance with Article 5 paragraph 1 letter a, or their practice personnel in accordance with Article 5 paragraph 1 letter b, may carry out the following treatments on eyelids or close to the eyes (up to 10 mm):
a. removing permanent make-up;
b. removing tattoos and telangiectasia (couperose);
c. treating spider naevi and haemangioma.
2.3 Only physicians qualified in accordance with Article 5 paragraph 1 letter a, or their practice personnel in accordance with Article 5 paragraph 1 letter b, may use the following techniques and processes:
a. highly focused ultrasound;
b. ablative laser;
c. long-pulsed Nd:Yag laser;
d. photodynamic therapies combined with the application of phototoxic substances or medicaments;
e. laser lipolysis.
To obtain the certificate of competence for each treatment according to Number 1, the following knowledge and skills must be acquired:
3.1.1 knowledge of the biological and physiological effects of optical radiation, radiofrequency, cold, shockwaves and ultrasound;
3.1.2 general knowledge of the anatomy, physiology and pathophysiology of human skin and hair, and specific knowledge of changes in skin, vessels, nails and tissue for treatments specified in Annex 2 Number 1;
3.1.3 fundamental knowledge of benign and malignant changes of the skin;
3.1.4 fundamental knowledge of the assessment of skin, hair, vessels, tissue and nails with regard to specific treatments;
3.1.5 recognition of a medical treatment indication and the need for referral to a physician;
3.1.6 knowledge of treatment site preparation and aftercare, hygiene and auxiliaries;
3.1.7 knowledge of the applicable legal provisions; in particular, those treatments which may only be carried out by a physician.
To obtain the certificate of competence for each treatment in accordance with Number 1, the following specifically required technical knowledge from the following list must be acquired: 3.2.1 knowledge of the principles and design of an IPL or laser device, laser classes, risks of reflective surfaces and health risks (eye damage, dazzling); 3.2.2 knowledge of the physical fundamentals of optical radiation, radiofrequency, cold, shockwaves or ultrasound; 3.2.3 knowledge of the technology of the devices that function with optical radiation, radiofrequency, cold, shockwaves or ultrasound; 3.2.4 knowledge of protective measures for operators as well as for clients.
To obtain the certificate of competence for each treatment according to Number 1, the following specifically required technical knowledge from the following list must be acquired: 3.3.1 knowledge of exclusion criteria, possible adverse effects, risks and alternative methods and technologies for the treatments listed in Annex 2 Number 1; 3.3.2 knowledge of the treatment schedule for the treatments listed in Annex 2 Number 1; 3.3.3 knowledge of suitable and unsuitable technologies used for the treatments listed in Annex 2 Number 1; 3.3.4 specific practical experience of the treatments listed in Annex 2 Number 1; 3.3.5 recognition and management of undesirable side effects and complications, in particular recognising those requiring treatment by a physician; 3.3.6. recognition of incorrect settings and equipment defects.
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