Miramar Labs said today it won FDA 510(k) clearance for its miraDry system, indicated for treatment and permanent reduction of underarm hair of all colors.
The device uses a proprietary microwave energy platform to remove hair, the Santa Clara, Calif.-based company said. This allows the device to permanently reduce hair of all colors, something limited by laser hair removal systems, the company said.
“This approval further validates Miramar’s unique technology in creating and addressing aesthetic markets that could not be fully satisfied with other energy platforms. We believe the potential for microwave energy in aesthetics is exceptional. Miramar was the first company to receive clearance for axillary sweat reduction and we are now the only company with FDA clearance for permanent reduction of axillary hair of all colors. These are both tremendous market making opportunities in aesthetics,” CEO Mr. Michael Kleine said in a press release.
The FDA clearance makes it the 1st device cleared that treats and permanently reduces underarm hair of all colors as well as permanently reducing underarm sweat, the company said.
“Based on the results we’ve seen using miraWave it’s clear that microwave energy has a role to play in the long term hair reduction space. Using this technology we’ve seen stable axillary hair reduction of approximately 70% regardless of color, and these results were based on a non-optimized treatment protocol. It will be exciting to see the increase in results given the protocol improvements we’ve made since then,” Dr. Jeremy Brauer of the Laser & Skin Surgery Center of New York said in a prepared statement.
The company has launched miraSmooth treatment with the device as an aesthetic procedure available to plastic surgery and dermatology practices. Miramar said it will be available in select markets in August 2015.
“I’m extremely excited about this significant advancement in hair removal and am just as pleased to announce that our center will begin to offer miraSmooth to patients. With miraSmooth I can offer hair removal to patients that could not be treated with lasers before or for those that desire elimination of sweat along with their axillary hair. A premium procedure such as miraSmooth fits into our practice offerings nicely,” Marina Plastic Surgery medical director Dr. Grant Stevens said in a press release.
Last February, Miramar raked in $10 million Series D round it planned to use to boost sales of its earlier miraDry system, a laser-based treatment for excessive underarm sweat.