The Botticelli (Model: Athena)

The Botticelli (Model: Athena) is a cart-based laser surgical system containing three individual lasers (1470 nm diode, 1927 nm thulium fiber, and 2910 nm erbium fiber) designed for dermatological and plastic surgery procedures. It is indicated for soft tissue coagulation, skin resurfacing, treatment of pigmented lesions, wrinkles, actinic keratosis, and scar revision, and is delivered via fiber-optic handpieces with integrated aiming beams.

The device features three distinct laser subsystems with varying wavelengths and spot sizes (100-430 microns depending on laser type), adjustable pulse parameters (0.2-300 Hz repetition rates, 10ms-2.5s pulse widths), fiber-optic delivery with microprocessor control, water-to-air cooling, and a 24-inch touch screen interface. Output power ranges from 0.5W to 15W for the 1470 nm laser, 5W for the 1927 nm laser, and 10W for the 2910 nm laser.

ISO 14971:2019 (risk management), IEC 60825-1:2014 (laser safety), IEC 60601-1:2005/AMD1:2012/AMD2:2020 (medical electrical equipment safety), IEC 60601-1-2:2020 (electromagnetic compatibility), and FDA guidance for software verification and validation in medical devices.

The Botticelli is substantially equivalent to three predicate devices (CHARISMA/REGAL, LASEMD, JOULE ProFractional) because each laser subsystem shares the same wavelength, product code (GEX), laser class (Class IV), delivery method, control system, and regulatory classification. The indications for use are identical or are subsets of the predicate devices' indications, and nonclinical testing demonstrates equivalent safety, effectiveness, and performance.