Legend X Platform

The Legend X Platform is a software-controlled dermatological device that delivers radiofrequency (RF) energy for skin ablation and resurfacing, and electrical stimulation for treating wrinkles, rhytides, and facial/body muscles. It consists of a console with touchscreen interface, foot switch, applicators, and disposable tips, and operates only under continuous direct user control with direct visualization.

The proposed device is substantially identical to its predicate (K232903) in console functionality, foot switch, and patient-controlled manual switch. Key differences are: two applicators (1-2) now include an integrated secondary temperature sensor with no change to intended function; minor updates to power density specifications (increased to 30 mW/cm², still below FDA 0.25 W/cm² limit); minor updates to current density for Applicator 2 (4 mA/cm², justified by temperature indicator risk mitigation); and minor GUI updates. One disposable tip (H7x7L in predicate) was replaced with H7x7 in proposed device.

ISO 11135:2014 (EO sterilization), ISO 10993-1/5/10/11/23 (biocompatibility), AAMI TIR-30:2011 (cleaning), ASTM F1980-16 and F1929-15 (sterile barrier packaging), ISO 11607 (packaging), IEC 60601-1:2005 and IEC 60601-1-2:2014 (electrical safety and EMC), IEC 60601-2-10:2016 (nerve and muscle stimulator requirements), IEC 60601-2-2:2017 (high-frequency surgical equipment), and FDA 2023 Guidance on Device Software Functions.

The device is substantially equivalent because it maintains identical indications for use, similar technological characteristics, and component design as the predicate. The added temperature sensors on Applicators 1-2 function as a risk mitigation and do not change intended functionality or operating mode. Updated power and current density specifications remain within established safety limits (rms power density 0.03 W/cm² well below 0.25 W/cm² FDA limit; current density of 4 mA/cm² justified by added temperature monitoring and low power density per IEC 60601-2-10). Additional verification and validation testing confirms the modified system conforms to design specifications and raises no new safety or effectiveness questions.