Lasers have been used for aesthetic treatments in the clinical environment for many years for procedures such as hair removal, skin rejuvenation and even liposuction. Now, with advances in miniaturisation, aesthetic laser treatments are finding their way into the home. The first application to make the leap from clinic to consumer was hair removal – light-based home-use devices for hair removal can now be found on store shelves next to the hair straighteners, electric toothbrushes and epilators.
In the last twelve months another procedure has made the leap from clinic to consumer: skin rejuvenation. Two companies – first Palomar in the US and then Philips in the UK and the Netherlands – have launched laser-based home-use devices for skin rejuvenation. The devices promise to improve the overall appearance of skin, reduce fine lines and smooth out wrinkles.
And there are plenty more companies developing products who want a share of this lucrative market.
‘The home-based market is the fastest growing medical sector for lasers,’ says Matthias Schulze, director of marketing for OEM components at Coherent. ‘We are experiencing stellar growth in aesthetic lasers for the clinical environment and predict that growth in lasers for the home-use market will be even higher.’
Stuart Nunn, technical sales engineer at UK company Laser Components, agrees. He told Electro Optics: ‘We have been receiving an increasing number of enquiries from customers looking to enter the at-home laser-based skin rejuvenation market. The majority of these enquiries have come from customers already active in the at-home hair removal market. This market uses mainly 808nm laser diodes whereas skin rejuvenation requires diodes with wavelengths around 1470nm. Laser manufacturers need to get the cost of these laser chips down to a level where our customers can integrate them into affordable products.’
Information on upcoming products in this area is incredibly hard to come by due to commercial sensitivities, but industry sources tell Electro Optics that many of the major clinical equipment suppliers are developing home-use products. While this may seem counter-intuitive – home-use devices could potentially take business away from the clinics – system manufacturers believe the at-home market will stimulate the clinical market. Consumer products are always backed by expensive advertising campaigns and these will raise consumer awareness of laser-based skin rejuvenation in clinics as well as at home.
But the consumer market is a challenging one for laser suppliers and system developers. While clinical instruments sell for five- or even six-figure sums, consumer devices are selling for under $800, with further price reductions predicted. While miniaturisation and cost reduction are major engineering challenges, developers have the added challenge of introducing extra safety measures as the devices will be used without trained supervision.
Palomar, a leader in supplying lasers and intense pulsed light systems to clinicians, was the first company to overcome these challenges and launch its home-use product, the PaloVia, at the end of 2010. Like other laser equipment manufacturers who have no experience of selling directly to the public, Palomar teamed up with a consumer company, in this case Johnson and Johnson, to develop the device. The two companies collaborated for five years after which Johnson and Johnson made the decision to pull out of the project for financial reasons. According to a Palomar statement at the time: ‘With this decision, Johnson and Johnson avoids having to make a large commercialisation payment to Palomar and avoids having to commit to the significant level of funding required to successfully launch a new product into the mass market.’
Palomar successfully gained FDA clearance for the PaloVia in 2009, and the device is now sold through various consumer channels such as the QVC shopping network.
As with Palomar’s clinical systems, the PaloVia is based on fractional non-ablative laser technology (see box). ‘The PaloVia uses a 1.41µm diode laser in a package especially developed by Palomar,’ explains Gregory Altshuler, senior vice president of research at Palomar. ‘Bringing costs down to the required level was challenging at the beginning because the initial quantities required were relatively low. We had to develop our own laser diode package to be successful.’
Being first onto the market was a risk, admits Altshuler. ‘But we are very proud of this accomplishment,’ he says. ‘And it gives us a head start and more time to make our second generation product even better.’
The device being marketed by Philips, the RéAura, was developed together with laser systems supplier Solta. It is also based on a diode laser (1435nm) and fractionated non-ablative technology. The main difference between the two devices is the scanning method used to deliver the laser power to the skin.
The laser in the PaloVia is coupled into an optical fibre which has a microlens at its tip. This tip focuses the laser beam beneath the skin tissue to create a micro-column of treated tissue that extends deeply into the skin. Consumers using the PaloVia laser use a stamping action. They place the device on the skin, ensure that the contact sensors are engaged, and press the activation button. The tip is mounted on a precision XY-stage, controlled by a microcomputer in the device. When the user presses the activation button and all safety conditions are satisfied, the software moves the tip according to the pre-programmed two-dimensional pattern, pulsing the laser at the desired locations to create the fractional treatment in the skin. Each scan takes about three seconds and then the consumer moves the device to another skin location. The device allows 25 stamps and then automatically shuts down for eight hours. ‘This stamping mechanism is ideal for treating delicate areas, such as eye wrinkles, as it allows the user to be very precise,’ says Altshuler. ‘The efficacy of our device is also independent of the consumer. It does not rely on the consumer to get it right.’
Users of the RéAura, on the other hand, use a more fluid motion when treating their skin. ‘The RéAura features a high repetition rate fractional laser beam delivery system which includes movement tracking,’ says George Frangineas, director of laser technology at Solta. ‘It uses a control algorithm that delivers a specific and predictable dose onto each area of the skin. Users simply glide the handpiece over their face and the laser automatically delivers the right dose, correcting for the variable movement speed. This means the user performs multiple passes over the same area of skin, producing a uniform treatment without printing stamp-zones of demarcation.’
To prevent consumers overusing the device, Philips advises that they treat their skin in ‘zones’- for example, the forehead is one zone and one half of the lower face is another zone. According to Philips, the device knows when exactly the correct dosage has been administered to each zone and it plays a ‘dose complete’ tune to alert the user to move on to the next zone. In addition, to prevent over-treatment, RéAura does have an automatic cut-off that blocks the device for 24 hours.
Unlike the PaloVia, the RéAura does not yet have FDA approval, which means it cannot be sold in the US. However, the PaloVia is only FDA approved for use on wrinkles around the eyes, which restricts Palomar’s advertising campaign as the company is not allowed to make claims about the efficacy of the device on any other part of the body. Philips, on the other hand, does not have these restrictions and its marketing campaign claims the RéAura is effective for the whole face, neck, chest, forearms and hands. In a statement released for Electro Optics, Philips states that: ‘The RéAura is currently only available for the European market. Philips is in the process of receiving 510k approval from the FDA and hopes to launch RéAura in the US in the coming years.’
Professor Christopher Zachary is chair of the Department of Dermatology at the University of California in Irvine. He sits on the Scientific Advisory Board for the Solta/Philips project and works with several laser companies on new technology. He says: ‘If an at-home device is powerful enough to do good, then it is powerful enough to cause complications so any company entering this market will need to develop safety mechanisms. Both these devices work and both are safe. It will be interesting to see what marketing strategies the companies use.’
Zachary believes the at-home market is not a threat to the clinical market: ‘I am totally in favour of the development of home-use devices so that patients might perform facial rejuvenation (or other treatments like hair removal) in the comfort of their own home. It just makes sense, both economically and for the sake of convenience. This is not to say that laser surgeons should be worried they are going to lose any business. It’s probably a different and more expanded group of individuals who will buy these devices.’
As consumers become more aware of this technology, more companies will enter the market for a slice of the action. UK company CyDen, who already has a hair removal product on the shelves of the UK’s largest pharmacy chain, Boots, has hinted that it is looking into the skin rejuvenation market. The company declined to be interviewed, but on its website it states: ‘Through the work carried out by CyDen on hair and on port wine blemish removal, it was discovered that, by altering the length and intensity of the light pulses, a patient’s skin became plumper and softer when exposed to CyDen’s IPL light. CyDen’s founders filed the first FDA Clearances in this area. Look out for an exciting announcement on how consumers will be able to benefit later in 2011.’ As this issue of Electro Optics went to press, this announcement had not yet been made.
US laser systems supplier Cynosure is also known to be working with cosmetics giant Unilever on a home-use light-based skin rejuvenation product, but, again, the company declined to be interviewed.
Pantec Biosolutions, based in Lichtenstein, is also working on an at-home version of its professional laser system – Precise Laser Epidermal System (P.L.E.A.S.E.). Unlike the other devices on the market, Pantec’s platform is based on an ablative technology using an Er:YAG laser at 2940nm. Like the non-ablative technologies, Pantec’s system uses a laser scanner to create an array of micropores in a predefined area. However, its ablative technology can also be used for transdermal delivery of drugs or cosmetics. Stefan Summer, product manager at Pantec, confirmed that the at-home device will be based on the same platform as its professional products, ‘meaning a miniaturised diode-pumped Er:YAG laser (2940 nm)’. Pantec’s professional platform has been developed together with laser diode suppler Oclaro, however Summer does not comment on how Pantec will ensure this technology will be made affordable for home use.
As with other devices on the market, Pantec aims to get FDA approval for its P.L.E.A.S.E Private device. ‘We are confident that we will get FDA approval,’ says Summer. ‘By having the P.L.E.A.S.E. Professional on the market means the reliability and safety of the device will be shown. Furthermore, several other home-use devices will be on the market by then and the FDA will have more practical experience with home-use devices.’
Meeting regulation requirements is often one of the biggest hurdles a new product has to overcome. The at-home light-based device market is so new and evolving so quickly that regulations have not yet caught up.
In the US, the FDA regulates the sale of consumer-use light-based products and treats them as medical devices requiring pre-marketing clearance before they can be offered for sale. In Europe however, the equivalent organisations, such as the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) does not regulate such consumer devices used for hair removal or wrinkle treatments as they consider these cosmetic applications and outside of their scope of responsibility. The only requirement is that such products meet European Directives and carry the CE mark.
Currently, there are no British or international standard specifically covering home-use light-based devices and it is unlikely that any such standard will be available before the end of 2013.
The consumer market is very fragile – one accident or mistake and the whole market’s reputation could be ruined. To protect this fragile market, large companies are taking steps to ensure consumers use their products safely, despite there being no legal requirement for them to do so. For example, in the UK the RéAura is sold through the online cosmetics shopping site Space NK. Unlike most products on the site, consumers cannot simply buy the product online – they must phone Space NK where a skin analysis is then undertaken as part of the registration process for online support.
‘Companies such as Philips don’t want smaller companies coming onto the market and ruining the reputation of the technology,’ says Godfrey Town, an UK-based independent laser protection advisor. ‘That is why they are keen to develop standards and tighter regulation of the market.’
Town is part of an international task force of scientists and clinicians from the European Society for Laser Dermatology which is calling for tighter guidelines on the safety of light-based home-use devices. The initiative has the backing of all the large players in this industry.
‘Europe is tightening its regulations covering professional providers of light-based therapy but because the at-home devices are not classed as medical devices, these tighter regulations will not impact the consumer market,’ says Town. ‘There is an urgent need for specific regulation of light-based devices for use in the home.’
