Coolfase

Coolfase is an electrosurgical unit that uses high-frequency radiofrequency current to coagulate tissue and achieve hemostasis. It consists of a main body, handpiece, and interchangeable tips, and is used with a grounding pad, coupling gel, and foot switch. It is indicated for dermatologic and general surgical procedures for electrocoagulation and hemostasis on intact skin.

Coolfase uses monopolar RF electrode technology at 6.78 MHz ± 10% frequency with a maximum output power of 140W, compared to the predicate's 400W. It has three electrode sizes (0.25, 4.0, and 16 cm²), manual or footswitch operation, LCD touchscreen user interface, and weighs 20 kg. The device operates at 100-240V, 50/60 Hz input with 400VA rating, and is provided as non-sterile with single-use electrodes.

Ex vivo side-by-side thermal performance testing on tissue was performed in accordance with FDA's 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' Guidance (March 2020). Biocompatibility, electromagnetic compatibility, and medical electrical equipment safety standards compliance are cited.

Coolfase is substantially equivalent to the Thermage FLX system predicate because both share the same monopolar RF electrode technology, frequency band, anatomical site (intact skin), operational modes, and user interface. Although Coolfase has lower maximum output power (140W vs 400W), this difference is within the predicate's power range and does not raise new safety or effectiveness questions. Thermal performance testing demonstrated comparable tissue coagulation effects and safety profiles between the devices.