The U.S. Food and Drug Administration has given 510(k) clearance to Reliant Technologies Inc. for three novel Fraxel re:pair laser hand pieces. This enhanced potential of the Fraxel re:pair laser system will provide physicians with an option for surgical treatment and skin resurfacing. As part of the Fraxel re:pair Complete Fractional Ablative Workstation, all of the three surgical hand pieces can be used alone or along with each other, with no need to turn the system off for changing the hand pieces.

The U.S. Food and Drug Administration has approved safety labeling revisions for Photocure’s Metvixia (methyl aminolevulinate HCl 16.8%) for use with the company’s Aktilite CL238 lamp. The site of treatment becomes photosensitive during the period between application of the cream and red-light illumination. That is why FDA has warned of adverse effects of dermal photosensitization, advising patients to avoid exposing the area to bright light. Sunscreen does not help in the protection of treated lesions. Patients should stay away from sunlight for two days after the therapy. FDA has also laid down that only trained physicians can apply the Metvixia cream.

The U.S. FDA has approved EVOLENCE for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. EVOLENCE is a new generation collagen-based structural dermal filler. Its introduction marks the first dermal filler entry for the Aesthetics Group of OrthoNeutrogena. Collagen, comprising up to 80% of the dermis, forms natural and abundant building blocks that help the skin to maintain its strength. As one becomes older, collagen naturally breaks down and the face is full of wrinkles, lines and folds.

EVOLENCE and its proprietary GLYMATRIX Technology use collagen from natural sources to compensate for the lost collagen in the body. This adds volume and structural support in depleted areas, for a more naturally youthful appearance. There is no need of any pre-test, but the durability assured is unparallelled.

According to Medicis Pharmaceutical, the FDA’s waiver provisions for the generic versions of the company’s once-daily oral acne drug, Solodyn (minocycline HCl), will put patients at risk. The company is asking the FDA to approve Solodyn’s generic versions only after in vivo bioequivalence testing for drug strength.

The FDA has granted clearance to Cynosure’s TriActive LaserDermology System, which is a cellulite treating system based on laser. In addition to the system’s apparent effect on cellulite, it also relives patients of minor pain and muscle spasms. TriActive LaserDermology System improves circulation as well and can be used with various plastic surgery procedures.

The Food and Drug Administration (FDA) has approved a drug that reverses the numbing effects of local anesthesia used by dentists. OraVerse, which was developed by Novalar Pharmaceuticals Inc. is the first dental anesthesia reversal agent on the market for patients of age 6 years or more. According to clinical studies, OraVerse reduces the time it takes for the effect of Novocaine and other numbing agents to wear off to half. Novalar aims to start selling the product in October.

VeraFil saline implants have been approved by the FDA for soft tissue reconstruction around the eye. This technology has been used for years in Europe and South America as permanent lip augmentation, under the name FulFil. The VeraFil implant is made from highly biocompatible materials, with a long track record of safety in the human body, and is designed to remain flexible.