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#120477 - 01/09/16 01:52 PM MiroSmooth cleared by FDA
Deedra Offline

Top 10 Contributor

Registered: 08/02/18
Posts: 9720
Loc: United States
New microwave device cleared by FDA. It destroys hair and sweat glands, regardless of hair color or skin color. Cost for device is close to $85,000.


Text from link:

SANTA CLARA, Calif., July 23, 2015 /PRNewswire/ -- Miramar® Labs, an innovative global aesthetic company, announced today its miraDry® System received clearance from the U.S. Food & Drug Administration (FDA) for the treatment of unwanted underarm hair, and permanent reduction of underarm hair of all colors. This announcement establishes miraDry as the only technology FDA cleared for the treatment of underarm hair of all colors as well as the permanent reduction of underarm sweat.

"This approval further validates Miramar's unique technology in creating and addressing aesthetic markets that could not be fully satisfied with other energy platforms," commented Mr. Michael Kleine, CEO and President of Miramar Labs. According to Mr. Kleine, "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."

Miramar Lab's proprietary miraWave® technology –use of precisely controlled microwave energy - is the foundation of the miraDry System. The permanent reduction of hair of all colors using miraWave is a significant technological advancement in the hair removal industry. Unlike laser hair removal systems, microwave energy doesn't require a chromophore to be effective and therefore can be used on hair of all colors, including light colored hair, and is also not limited by an individual's skin color.

"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," said Dr. Jeremy Brauer, Laser & Skin Surgery Center of New York. "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."

With this clearance, the company has announced the introduction of the miraSmooth treatment. The launch of miraSmooth is a perfect addition to plastic surgery and dermatology practices looking to offer their patients the latest in aesthetic procedures. miraSmooth™will be made available in select markets beginning August of 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," added Dr. Grant Stevens, Medical Director of Marina Plastic Surgery. "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."

About Miramar Labs:

Founded in 2006, Miramar Labs is a privately owned global medical device company dedicated to bringing the next generation energy modality to the field of dermatology. Supported by rigorous clinical research, Miramar Labs is focused on addressing aesthetic medical conditions for which there are significant unmet clinical needs. The company's first priority is advancing aesthetic treatments using its proprietary miraWave technology. Physicians and patients are encouraged to visit for additional information about Miramar Labs.

SOURCE Miramar Labs

Dee Fahey RN CT LLC

Licensed by the State Medical Board of Ohio for Cosmetic Therapy/Electrolysis and the State Nursing Board of Ohio

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#120487 - 01/10/16 12:14 PM Re: MiroSmooth cleared by FDA [Re: ]
Laurier Offline
Top 10 Contributor

Registered: 03/05/11
Posts: 504
Loc: Upstate New York
FWIW that just means they don't think it'll kill anybody.
Makers of the Laurier Insulated Bulbous Probe.

"The perfect violin is worthless unless in the hands of one who can play it well"

#121105 - 03/01/16 07:47 PM Re: MiroSmooth cleared by FDA [Re: ]
Arlene R. Batz, CPE Offline

Top 10 Contributor

Registered: 01/14/05
Posts: 1172
Loc: New York City - Queens
Thank you for posting Dee. I am wondering if the treatment will be used to treat other areas and the effect of destroying sweat glands.
Arlene Batz, CPE: Educator, Board Certified Electrologist, NYS Licensed Esthetician.

#126286 - 04/17/18 05:25 PM Re: MiroSmooth cleared by FDA [Re: ]
Bonet Offline

Registered: 04/15/18
Posts: 5
now that is hot


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