BLESSING System

The BLESSING System is an electrosurgical coagulation device intended for dermatologic and general surgical procedures to achieve electrocoagulation and hemostasis. It operates via high-frequency (RF) energy at 1 MHz and 2 MHz, applying electrical current through handpiece electrodes to generate heat that coagulates tissue, with maximum output power of 30W at 200Ω load.

The subject device operates in bipolar/monopolar RF mode with frequencies of 1 MHz/2 MHz, maximum output power of 30W (vs. predicate's 50W), voltage output of 0–77.5V (vs. predicate's 0–100V), treatment duration of 10–990 ms, and needle diameters of 0.28–0.33 mm. It features three handpiece types (DRS, VRS, ORS) with tips containing 1–49 needles and operates at intensity levels 0–10. Input voltage is 100–240VAC, 50/60 Hz, 180VA.

EMC testing per IEC 60601-1-2:2014/AMD1:2020; electrical safety per IEC 60601-1:2005 + amendments and IEC 60601-2-2:2017 + AMD1:2023; usability per IEC 60601-1-6:2010/AMD2:2020. Biocompatibility tests included ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-11:2017 (skin irritation and acute systemic toxicity), USP 151-2022 (pyrogen), and ISO 10993-4:2017 (hemolysis). Validation included cleaning, sterilization, shelf-life, software, and performance testing.

The BLESSING System is substantially equivalent to POTENZA (K201685) because both share identical indications for use, system type (bipolar/monopolar RF), and frequency (1–2 MHz). Although the subject device has lower maximum power (30W vs. 50W), lower voltage output (0–77.5V vs. 0–100V), and minor differences in handpiece nomenclature and needle specifications, these differences do not raise safety or effectiveness concerns because the lower power and voltage remain within safe operating ranges, the needle quantities (1–49) fall within predicate ranges, and biocompatibility and electrical safety testing confirm safety. The operational modes, treatment duration, sterilization method, and single-use designation are equivalent or functionally identical.