Demand for OTC laser, light devices continues to grow

August 1, 2011

Producing home devices introduces a challenging balance between efficacy and safety. Safety issues include those for the treatment area, as well as for the eyes. Some device fluences even have been changed post-introduction due to concerns over the retinal hazards. Despite these challenges, several at-home laser and light devices have been cleared by the Food and Drug Administration (FDA) over the past six years.

Key Points

Producing home devices introduces a challenging balance between efficacy and safety. Safety issues include those for the treatment area, as well as for the eyes. Some device fluences even have been changed post-introduction due to concerns over the retinal hazards.

Anti-aging efforts

Patients are instructed to use the device daily for one month (induction phase) and then twice a week indefinitely. There is no numbing cream required or packaged with the device, eliminating one possible safety issue. Treatments are slightly painful, but they are tolerable for most users. The higher settings on the PaloVia are very similar in energy to those that I frequently use in-office for the chest.

In a multicenter trial including 124 patients and 6,000 treatments (Leyden J, Stephens T. Abstract presented at: 30th Annual Conference, American Society for Laser Medicine and Surgery; April 16-18, 2010; Phoenix), 90 percent of users had at least a one-point improvement in the Fitzpatrick wrinkle score after the active phase, and 79 percent had at least a one-point improvement in wrinkle score after the end of the maintenance phase.

A skin sensor will allow the laser to fire only when it is in direct contact with the skin and with the coupling gel. Without full skin or gel contact, the laser will lock and not fire. Another safety feature to prevent overuse is the shut-out feature, which prevents the user from re-treating within a specific window of time (eight hours).