Over the past several years, over-the-counter (OTC) cosmetic laser and light devices have been introduced and aggressively promoted for consumer home use. On late night infomercials, in tabloid magazines, online, through various healthcare related venues—seems as if they are everywhere. Neat devices that promise to remove wrinkles at home, zit-zappers that get rid of that pimple by happy hour, grow hair—remove hair, take your pick. As a cosmetic dermatologist, I am often asked my opinion about these devices, if they work and if they are worth it.
There are 3 criteria to consider that will help you make the decision whether home laser and light treatments make sense for you: Is it safe? Is it effective? Are the results worth the money?
There are obvious advantages for consumers when compared with in-office treatments, most prominently the ability to perform treatments at home, and for potentially less cost than professional office based treatments. On the other hand, these devices are much less powerful than comparable office based lasers and light treatments, both to make them affordable to consumers and to allow them to be safely used by non-medical operators. This results in the need for a greater number of treatments, longer treatment times, and less effective treatments.
If you are considering using one of the devices, you do need to consider the way these home devices are regulated by the Food and Drug Administration (FDA) so that you are not misled on their safety and efficacy. Devices are equipment, and the FDA classifies medical devices based on the risks associated with using the device. Devices are classified into one of three categories—Class I, Class II, and Class III.
Drugs and serious high-tech medical devices such as implantable heart defibrillators are Class III devices and must always be “approved” after going through serious testing to establish both safety and effectiveness. Less-invasive medical equipment falls into Class II. This is a broad category, as it includes some hospital and office use medical devices as well as some home use devices such as home skin laser devices and wheelchairs.
Class II devices may be “approved” or “cleared.” “Cleared” Class II medical devices are ones that FDA has determined to be “substantially equivalent” in mechanism to another legally marketed device, whether or not that device actually works, and is not an indication that the cleared device has been proven effective. Home skin lasers, if they have any FDA certification, fall into the cleared category. An “approved” Class II medical device has gone through a much more rigorous process demonstrating both safety and efficacy, and is used for the more high risk devices in this category such as medical use skin lasers. Class I devices are very low risk devices, such as tongue depressors and dental floss.
Let’s review the home laser and light treatments that generally fall into 4 groups: Photorejuvenation, Hair Growth, Hair Removal and Acne Treatment.
A number of these home devices can give you some results while incorporating safety features that may make them acceptable treatment options. They are all very significantly less powerful than the office based devices which mean less improvement and more treatment time. Many require bulb or head replacements at intervals. The specific devices reviewed are some of those with some published evidence about safety and results. There are plenty of others with no evidence of safety or results, and none of the devices have anywhere near the amount of studies required of more powerful, office based devices. Don’t overestimate the meaning of FDA’s terminology of “cleared as substantially equivalent” to existing devices. It is not an endorsement of effectiveness. That said it is possible one of these devices will be helpful for you. If you are going to use them, use one that has some published safety and effectiveness studies.
Please note: I am not endorsing any specific device and have no association with any device. We do not sell any of these devices. And I am tired of the word “device.”
If you have any questions on skin rejuvenation all in one machine. We will give the professional answers to your questions.