DUET-V (Model: ESK-3261DV)

The DUET-V (Model ESK-3261DV) is a radiofrequency electrosurgical device system operating at 4 MHz used for dermatological and surgical procedures. It features disposable, single-use treatment tips in two categories: Fractional RF Tips (FRF) for skin ablation and resurfacing, and Thermal RF Tips (TRF) for electrocoagulation in dermatologic and general surgery.

The device uses 4 MHz radiofrequency energy with 250VA maximum power, hand-held design with removable exchangeable electrodes, and three operational modes (Shot, Auto Shot, and Continuous). It includes both monopolar electrodes (TRF tips with grounding pad) and bipolar electrodes (FRF tips without grounding pad), with multiple treatment levels and manual or footswitch control.

ISO 10993-5:2009 and 10993-10/11/23 (biocompatibility), IEC 62304:2006+A1:2015 (software life cycle), AAMI/ANSI ES 60601-1:2005+A1:2012 and IEC 60601-1-2:2020 (electrical safety and EMC), and IEC 60601-2-2 201.12.1.101 (ESU output accuracy).

The subject device demonstrates substantially equivalent design and performance to two predicate devices: the Thermage CPT System (K173759) for thermal RF tips and the Venus Viva MD (K201164) for fractional RF tips. Both share identical regulatory classification, similar indications for use, comparable RF energy delivery mechanisms, hand-held configuration, removable electrodes, and disposable single-patient tips. Performance testing confirmed equivalent electrical specifications, output accuracy within ±20%, temperature control within ±1°C, and identical operational modes, establishing functional equivalence despite minor frequency differences (4 MHz vs. 6.78 MHz or 1 MHz).