Confusion over high tech hair loss aids

LaserCombs are a relatively new class of product designed to fight hair loss combining a brush with a special light source. They’re sold online in the UK with the marketing information saying they are “FDA approved meaning the US health regulator has cleared them for use.

There’s no mention of them being UK approved, which is because they are not classed as health products here.

They are sold online in the UK for around £350, with promises of increased hair growth, cessation of hair loss, faster growing hair, more manageability and more vibrant colour.

The Medicines and Healthcare products Regulatory Agency (MHRA) says the devices do not fall under its remit.

Jennifer Kyne from the MHRA told us by email, Whether or not a specific product would be a medical device under Directive 93/42/EEC would depend on the claims being made for each individual product by its manufacturer. ’Hair loss’ or ‘balding’ is not regarded as being a medical condition and therefore products which claim to treat such problems will not be medical devices and would not require CE marking as such.

It should also be noted that the regulations in the USA are not the same as those in the EU and just because something has been FDA approved does not mean that it is a medical device under EU regulations.