A cosmetic therapy company has been fined $37,800 by the TGA for advertising and selling a microneedling device, Dermapen 4, that is not registered in Australia.
InSkin Cosmedics Group Pty Ltd, based in Sydney paid the penalties for supplying and advertising the device that is promoted for skin anti-ageing and treatment of scar tissue, pigmentation and acne.
The device website says Dermapen treatments can be effective for multitude of conditions including: rosacea, telangiectasia, seborrheic dermatitis, aesthetic gynaecology and alopecia. It claims the device has significant benefits over dermal-rolling and Fractional laser treatments, due to the minimal trauma associated with its use.
However the TGA said the device was not included on the Australian Register of Therapeutic Goods (ARTG) at the relevant times and it issued three infringement notices for alleged contraventions of the Therapeutic Goods Act 1989.
“Australia’s therapeutic goods legislation prohibits the import, export, manufacture, supply and advertising of therapeutic goods for human use that are not included in the ARTG or otherwise the subject of an exemption, approval or authority,” it said.
Dermapen also promotes a wide range of ‘dermaceutical’ topical skin products such as cleansers and exfoliants.