Accure Acne, Inc. announced it received FDA clearance (K242035) for the long-term treatment of mild to severe inflammatory acne vulgaris using its Accure Laser System. The laser utilizes a 1726 nm wavelength to target the sebaceous glands, providing a non-pharmacological option for acne management. This clearance follows clinical trials in the U.S. that demonstrated a 70% reduction in inflammatory lesions six months post-treatment, with four treatment sessions spaced a month apart.

The clinical trials included patients with varying severities of acne and all skin types, showing efficacy across diverse populations. The mechanism behind the Accure Laser involves precise thermal gradient control, achieved through proprietary technology, which optimizes the impact on sebaceous glands, according to a press release. Forced air cooling and real-time monitoring algorithms enhance the safety profile by regulating temperature during treatment.

The Accure Laser System underwent a limited commercial release in early 2024, during which it garnered positive feedback from both patients and clinicians. Satisfaction scores averaged over 4.4 out of 5. Following its initial U.S. release, the system has expanded to regions including the Middle East, Europe, the Caribbean, and Asia Pacific.

Emil Tanghetti, MD, a principal investigator in the clinical trials, noted the laser's unique technology may offer potential applications beyond acne treatment, including other dermatological conditions. Dr. Tanghetti highlighted the technical innovations of using temperature as an endpoint and the precision involved in the system’s real-time monitoring and cooling mechanisms.