Modern dermatology involves technologically advanced devices, meeting the diagnostic and therapeutic requirements.
Dermatology equipment may be classified into the following categories:
1) dermatology lasers (e.g. closing capillaries, eliminating unwanted hair, removing skin discolouration and tattoos, evaporating skin growths, regenerating and rejuvenating skin),
2) dermatoscopes and video dermatoscopes for diagnosis of skin neoplasms (cancers),
cosmetology devices: microdermabrasion, hydradermabrasion, cosmetic workstations, machines for permanent makeup,
4) ultrasound devices (firming the skin, introducing active ingredients to the skin),
5) other supporting equipment:
- cooling devices (cooling skin during laser therapy),
- laser smoke evacuators,
- ergonomic medical and cosmetic chairs,
- specialistic lighting (lamps used during diagnosis and treatments, lamps with magnifiers, ultraviolet lamp (Wood's lamp)),
- digital cameras for documentation before and after treatment,
- autoclaves for sterilization of reusable medical equipment,
- diathermy for coagulation of blood vessels during dermatosurgical treatments,
6) other: radio waves (firming the skin), endermologie (mainly for cellulite treatment);
FDA - Food and Drug Administration - is the US government agency, established in 1906. It is a part of the United States Department of Health and Human Services and is responsible the regulation and supervision of food safety (for human and animals), dietary supplements, medications (for human and animals), medical devices, electromagnetic radiation emitting devices (including non-medical devices), biological materials and blood and tissue products in the USA. FDA is known for its strict rules governing the issuance of marketing authorizations for medicines. These regulations impose on manufacturers to comply with the established procedures and to inform patients about the risks associated with the use of certain drugs. Positive opinion issued by FDA for a given product is respected also outside the USA as the confirmation of quality and affirmation of lack of negative influence on health. In case of devices, the FDA approval sets the safety and effectiveness standard, as the certificate issuance is preceded by multi-stage clinical trials.
Laser-Medica equipment with FDA certificate:
1) LightSheer Duet – April 2006 see
2) Vasculight Elite – October 2002 see
3) Fraxel re:store – October 2009 see
4) Medlite IV – January 2002 see
5) i-lipo Ultra – September 2010 see
6) Accent Elite – January 2011 see
CE marking is the manufacturer's declaration that the product meets the requirements of the applicable, so called New Approach directives of the European Union. These directives apply to issues related to the safety of use, protection of health and the environment, identify risks that the manufacturer should detect and eliminate. By affixing a CE marking to a certain product, a manufacturer confirms that the product conforms with all EC directives that apply to it. In order to mark a product with a CE marking, its producer performs analyses and takes action to comply with relevant directives, and then has the product evaluated with respect of compliance with applicable directives. The producer documents the process and results of the product assessment. If a given product is subject to even a single directive of the New Approach, it cannot be placed on the market without the CE marking within the EU.