RM STAR EX with RMS Needle

The RM STAR EX with RMS Needle is a bipolar radiofrequency electrosurgical device intended for use in dermatologic procedures to achieve electrocoagulation and hemostasis. It consists of a main body and handpiece that deliver RF energy at 2 MHz through penetrating needle electrodes in a consumable tip to create controlled heat within target skin tissue.

The device operates at a maximum output power of 16 W (50 Ω) at 2 MHz frequency with conduction times ranging from 100-200 msec (shorter than predicate's 120-300 msec). It achieves penetration depths of 0-2.0 mm (shallower than predicate's 0.3-4.0 mm) and uses 13-pin electrode configurations (fewer than predicate's 25-pin), all within a disposable consumable tip. Input voltage is AC 100-240 V, 50/60 Hz.

ISO 10993 series (biocompatibility including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity); ISO 11135, 11138, 11737, 11140, and AAMI standards for sterilization validation; IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, EN 55011, and IEC 61000-3-2 for electrical safety and EMC; ASTM F88/F88M-15, F1929-15, D4169-22, and F1980-21 for packaging and shelf-life validation.

The RM STAR EX is substantially equivalent to SYLFIRM X because both are bipolar RF electrosurgical coagulation devices with identical indications for use in dermatologic procedures, same operating frequency (2 MHz), same output power (16 W), same input voltage, and same prescription-use classification. Minor differences in conduction time, penetration depth, and electrode count do not raise safety concerns because the subject device's parameters are within acceptable ranges (shorter conduction times, shallower depths, fewer electrodes all represent conservative design choices), and safety and effectiveness were confirmed by animal testing showing controlled tissue interactions with good healing.