Miramar wins FDA nod for underarm hair reducer

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...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Cosmetic/Aesthetic Food & Drug Administration (FDA) Regulatory/Compliance Miramar Labs Inc. Source Type: news