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FDA Clears Accure Laser System for Acne Treatment

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11/28/2022
dermatologytimes.com

Photo: Pixabay 

DermatologyTimes.com

The US Food and Drug Administration (FDA) has cleared Accure Acne, Inc.’s Accure Laser System for the treatment of mild to severe inflammatory acne vulgaris.1 The success of the Accure Laser System is based on its unique 12726nm laser wavelength, adding proprietary technology to carefully control thermal gradient depth. The latest system uses Accure’s unique pulsing algorithm, integrated temperature monitoring, and automated laser control.

The FDA clearance is based on the Accure Laser System’s ability to selectively target sebaceous glands and the precise control of the laser and laser delivery into the dermis. Accure’s precise acne targeting also established the laser system as a breakthrough device among energy-based devices. The Accure Laser System is the first 1726nm-based laser platform with both FDA and CE Mark clearances.

The lead clinician of the Accure Laser System’s clinical development program, Emil A Tanghetti, MD, based out of The Center for Dermatology and Laser Surgery in Sacramento, California, stated that there is sufficient evidence suggesting sebaceous gland damage at depths unique to the Accure Laser System’s unique mechanism of action. Accure’s system is groundbreaking, but still simple to use, making it accessible to physicians across the industry.

Fernanda Sakamoto, MD, PhD, assistant professor of dermatology at Harvard Medical School and the lead author of the seminal research of 1726nm laser wavelength selectivity of sebaceous glands, noted that many patients with acne can fail treatments due to lack of compliance or contraindications to conventional medications. The Accure Laser System is a new energy-based device that dermatologists can learn to use in a controlled environment to treat their patients safely and effectively.

According to Accure Acne, acne vulgaris affects more than 50 million adolescents and adults annually, making acne of the most commonly treated skin conditions by healthcare providers.

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Schedule30 May 2023