AviClear Laser System

The AviClear Laser System is an infrared diode laser (1726 nm wavelength) designed to treat mild to severe inflammatory acne vulgaris by delivering controlled thermal energy to sebaceous glands, reducing sebum production. The device includes a console with touchscreen interface, two treatment handpieces with integrated scanners, and a temperature-controlled cooling window for epidermal protection.

The modified device introduces a new Large handpiece with a 3 mm × 3 mm square spot and rectangular arrays of up to 25 spots, and reduces post-treatment skin cooling duration from 2 seconds to 1 second. All other technological characteristics remain identical to the previously cleared AviClear Laser System (K230660).

IEC 60601-1 Ed. 3.2 2020 (general medical device safety), IEC 60601-1-6 Ed. 3.2 2020 (usability), IEC 60601-2-22 Ed. 4.0 2019 (surgical and laser equipment), IEC 60825-1 Ed. 3.0 2014 (laser product safety), IEC 60601-1-2 Ed. 4.1 2020 (electromagnetic disturbances), and software verification and validation testing.

A multi-center clinical study comparing the modified device to the predicate on pre-excised skin showed no new or unexpected adverse device effects, consistent safety profiles, and comparable histological thermal effects at equivalent settings. Histological assessment confirmed similar selective sebaceous gland destruction without epidermal injury, inflammation, or adjacent tissue damage, demonstrating that the handpiece design change and reduced cooling duration do not raise different safety or effectiveness questions.