Sunny

The Sunny is a high-frequency electrosurgical device with three operating modes: a 6.78MHz RF handpiece for dermatologic electrocoagulation and hemostasis, and 1MHz and 2MHz RF handpieces for topical heating to provide temporary pain relief, reduce muscle spasms, and increase local circulation. The non-invasive device is operated by medical professionals through an LCD interface and includes treatment tips, a neutral electrode pad, and refrigerant gas.

The Sunny RF handpiece operates at 6.78MHz with 120W maximum power and a 2.25cm² electrode, compared to the predicate Thermage CPT's 400W maximum and similar frequency. The Pulsar handpiece uses 1MHz and 2MHz frequencies with 40.5W and 20.2W maximum power respectively. Both devices deliver monopolar radiofrequency energy; the Sunny additionally includes bipolar capability. Energy output ranges from 25-135 Joules with adjustable power levels and operating modes (soft and hard for the Sunny RF).

IEC 60601-1:2005+A2:2020 (general safety requirements), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-2-2:2017+A1:2023 (high-frequency surgical equipment), IEC 62304:2006+A1:2015 (software lifecycle), EN ISO 14971:2019 (risk management), ISO 10993-1:2018 (biocompatibility), and IEC TR 60601-4-2:2016 (electromagnetic immunity guidance).

Both the Sunny RF and Pulsar handpieces share the same indications for use, frequency ranges, and mechanism of action as the Thermage CPT predicate. Although the Sunny operates at lower maximum power (120W vs. 400W for Sunny RF; 40.5W vs. 400W for Pulsar), thermal testing demonstrated the Sunny achieves comparable tissue heating effects at clinically relevant settings. The devices have similar energy output ranges, biocompatibility profiles, and electrode configurations. The additional bipolar functionality and soft-mode feature provide operational flexibility without affecting safety or effectiveness.