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FDA approval

Syneron Home Use Hair Removal Device Approved

Syneron Medical has received 510(k) clearance from the United States Food and Drug Administration (www.fda.gov) to market its me Home-Use Hair Removal System to consumers. The me hair removal system is the first and only FDA cleared consumer hair removal technology that is approved for all skin tones. It is also the first home-use product featuring Syneron's proprietary elos technology—which combines intense pulse light (IPL) and radiofrequency (RF) energies—to receive FDA clearance.

FDA Approves MelaFind

The MelaFind melanoma detection system from MELA Sciences has received United States Food & Drug Administration approval following its pre-market approval application submitted to the FDA in June 2009. Earlier this year, the company received CE Mark approval from the European Union for the device, which the company plans to roll out concurrently in 2012 in Germany and the United States. “We are thrilled that our years of persistence through the development and regulatory process have paid off,” said Joseph V. Gulfo, MD, president and CEO of MELA Sciences.

Restylane Approved For Lips

The United States Food & Drug Administration has approved Restylane (Medicis, www.restylaneusa.com) for lip augmentation. Although physicians have been using Restylane and other hyaluronic acid-based fillers off-label in the lips for several years, Restylane is the first hyaluronic acid filler approved for this indication.

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