VEGA

The VEGA is a high-power diode laser therapy device designed for long-lasting hair removal on all skin types. It features two interchangeable handpieces: a triple-wave applicator (755/810/1064 nm) for temporary hair reduction in Super Hair Removal (SHR) mode, and a dedicated 810 nm applicator for permanent hair reduction in both Hair Removal (HR) and SHR modes, measured at 6, 9, and 12 months post-treatment.

The subject device uses GaAlAs diode laser technology with wavelengths of 755, 810, and 1064 nm, delivered via sapphire-tipped handpieces with spot sizes of 10x30 mm. It operates at fluence levels of 1–8 J/cm² for triple-wave SHR mode and up to 21 J/cm² for 810 nm SHR mode, with pulse widths of 1–200 ms and frequencies up to 10 Hz. All parameters fall within or closely match predicate device specifications, with equivalent Class IV laser classification and color LCD touchscreen interfaces.

The device was tested in accordance with IEC 60601-2-22 (international standard for laser surgical instruments), which evaluates functionality, environmental compatibility, safety features, and user interface reliability and performance in non-clinical settings.

The VEGA is substantially equivalent because it uses identical laser technology (GaAlAs diode), the same wavelengths as predicates, and functionally equivalent delivery systems with comparable fluence and pulse parameters. Minor differences—such as spot size variation (10x30 mm versus 1.5–4.0 cm²) and slightly higher SHR fluence (21 versus 20 J/cm²)—do not introduce new safety or effectiveness concerns, as these parameters remain within published clinical literature ranges and established diode laser safety profiles. The indications for use are identical to predicates, and both the subject and predicate devices underwent the same non-clinical testing standard.