Youmagic FLM System (YM5-U1)

The Youmagic FLM System (YM5-U1) is a radiofrequency-based electrosurgical device indicated for dermatologic surgical procedures for electrocoagulation and hemostasis. It is a monopolar, conductive RF system that delivers RF energy while conductively cooling the epidermis through a disposable treatment tip, and is prescribed for use only.

The device operates at 6.78 MHz with 175W max power output, uses monopolar RF delivery with an NTC temperature sensor and impedance monitoring, and includes a cooling system with temperature detection control. Key differences from the predicate include: restricted indications (dermatologic procedures only, excluding wrinkle treatment and muscle-related uses), manual-only operation mode (vs. manual or footswitch), and slightly lower max power (175W vs. 173W at equivalent tip area).

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (irritation), IEC 60601-1:2020 (general safety), IEC 60601-1-2:2020 (electromagnetic disturbances), IEC 60601-2-2:2017 (high-frequency surgical equipment), and thermal effects testing per FDA guidance for electrosurgical devices.

The device is substantially equivalent because it shares the same fundamental RF technology, frequency (6.78 MHz), monopolar design, and core safety monitoring (impedance, temperature, continuity) as the predicate Thermage FLX System (K170758). Minor differences in indications, mode of operation, and power output do not raise safety or effectiveness concerns because: the proposed device's narrower indications are a subset of the predicate's uses; the restricted feature set poses no new risks; performance specifications are comparable; and compliance with the same IEC/ISO standards ensures equivalent mechanical and electrical safety.