AVAVA™ Skin Treatment System

The AVAVA Skin Treatment System is a 1550nm erbium glass laser used by medical professionals to treat acne scars and perform dermatologic procedures requiring soft tissue coagulation and skin resurfacing. The system comprises a console (control electronics and laser), tablet (touchscreen user interface), and patient interface (focusing optics and cooling tip), and is intended for use only by trained personnel in professional settings.

The AVAVA is a scanned pulsed 1550nm laser with a maximum output power of 30W (compared to the predicate's 20W), maximum pulse energy of 150 mJ, and maximum pulse width of 12 ms. It features a reusable sapphire cooled tip with continuous contact cooling, software control, and touchscreen interface. The key difference is the increased power output to improve treatment speed while maintaining identical pulse energy and pulse duration ranges.

Software verification and validation per FDA Guidance for Software in Medical Devices (2005) and IEC 62304:2006+A1:2015; Electrical Safety per ANSI AAMI ES 60601-1:2005(R)2012 and A1:2012; EMC testing per IEC 60601-1-2:2014-02; Risk analysis per IEC 14971:2007.

The AVAVA maintains identical intended use, operating principles, laser source type, maximum pulse energy (150 mJ), maximum pulse width (12 ms), tissue contact design, cooling mechanism, and software control as the predicate MIRIA device. Although output power increased from 20W to 30W, the pulse energy per treatment remained unchanged. Clinical evidence from 47 subjects (Fitzpatrick Types I-VI) demonstrated that the higher power does not alter coagulation zone geometry, does not increase patient risk, and achieves equivalent safety and efficacy for acne scar treatment (90.2% showed 1-point ECCA improvement).