Apollo Quattro (APQ-10M)

The Apollo Quattro (APQ-10M) is a multi-function electrosurgical device that delivers radiofrequency (RF) energy and thermoelectric cooling to treat minor muscle aches, pain, spasm, and skin lesions. It includes multiple handpieces for RF output (Q-LF, Q-FX, Q-SC, Q-BT) and a cooling handpiece (Q-EP) for dermatologic procedures and temporary pain/swelling reduction after minor surgery.

The device operates at 1 MHz bipolar RF with a maximum output of 42W (compared to predicate's 40W). It features multiple handpiece options and larger dimensions/weight than the predicate Apollo Duet. The cooling function uses thermoelectric cooling (TEC) with an integrated aluminum plate, eliminating the need for cryogenic gases. All user-contact materials are identical to the predicate (SUS 304 stainless steel and polycarbonate).

IEC 60601-1:2005/A2:2020 (basic safety and essential performance), IEC 60601-1-2:2014/A1:2020 (electromagnetic compatibility), IEC 60601-2-2:2017/A1:2023 (high-frequency surgical equipment), ISO 14971:2019 (risk management), IEC 60601-1-6:2010/A2:2020 (usability), IEC 62304:2015 (software), and ISO 10993-1 (biocompatibility).

The Apollo Quattro is substantially equivalent because it uses identical RF and cooling technology at the same frequencies and indications as the predicate devices (Apollo Duet for RF mode, Dermal Cooling System for cooling mode). Minor differences in dimensions, weight, and RF output power (42W vs. 40W) do not affect safety or effectiveness, and all testing demonstrates conformance with the same consensus standards as the predicates.