Oligio X

The Oligio X is a radio frequency therapy system operating at 6.78 MHz with a maximum power output of 140 W. It is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue. The device delivers RF energy through disposable tips while conductively cooling the epidermis to selectively coagulate tissue.

Key differences from the predicate device (K240313, also Oligio X) include: reduced maximum output power (140 W vs. 145 W), narrower main body dimensions (479 mm width vs. 580 mm), repositioned return pad location, added footswitch accessory, longer return cable (3.0 m vs. 1.7 m), new cooling gas formulation (R-1234ZE added), modified coupling fluid tube design, updated GUI design, and revised electrical system block and insulation diagrams. RF output frequency (6.78 MHz ± 1%), tip dimensions (0.25, 4.0 cm²), and operational modes remain identical.

Device compliance was verified against IEC 60601-1:2005/AMD1:2012 (medical electrical equipment general requirements), IEC 60601-2-2:2017 (high frequency surgical equipment), IEC 60601-1-2:2014 (electromagnetic compatibility), and IEC 61000-3-2:2018 (harmonic current emissions). Biocompatibility testing of the RF tip (polyethylene terephthalate) confirmed suitability for limited skin contact (<24 hours) per ISO 10993-1. Software was validated at MODERATE concern level.

Substantial equivalence is based on identical intended use, anatomical site (skin and soft tissue), and fundamental operating principle—both devices deliver RF energy for selective tissue coagulation with epidermis cooling. Although dimensional, accessory, and design modifications exist, these are characterized as marketing-driven changes that do not alter the basic function or safety profile. The slight power reduction (5 W decrease) is within a conservative adjustment and does not compromise the core therapeutic mechanism. No clinical studies were required because the predicate established safety and effectiveness for the same indications, and the proposed changes do not introduce new risks or failure modes.