Viol Sylfirm X

Sylfirm X is a radiofrequency microneedling system from VIOL Co., Ltd. of South Korea. FDA cleared it under K200185 on April 22, 2020 and again under K213612 on June 23, 2022. The system is a tall cart, about 1580 mm high, with a main unit, a handpiece that takes a consumable needle tip, and a foot switch. Its FDA indication is electrocoagulation and hemostasis, and the 2022 clearance limits that to dermatologic procedures.

Sylfirm X is bipolar, runs at 2 MHz and delivers up to 16 W into a 50 ohm load. It has two families of settings: four continuous wave modes, CW1 to CW4, each a single pulse of 120 to 300 ms, and four pulsed wave modes, PW1 to PW4, each a train of four pulses lasting 120 to 240 ms in total. Needle depth is adjustable from 0.3 to 4.0 mm in 0.1 mm steps. The original tip had 25 pins in a 5 by 5 grid at 2.0 mm spacing, and the 2022 clearance added the J25BM and J25BS tips with 25 pins and the J18BS with 18 pins in a 3 by 6 grid at 1.5 mm spacing.

VIOL makes other RF systems that can turn up in the same practices, among them Celfirm and Scarlet SRF, which were the predicates for Sylfirm X, and the later Scarlet Pro. They are separate models, so confirm that the label reads Sylfirm X.

Tips are sterile single use parts, sterilized with ethylene oxide, so they are a running cost for whoever buys the system. List any unopened tips with their codes, such as J25BM or J18BS, and their expiry dates. A buyer will also want to know the handpiece condition, the software version, the service history and whether the foot switch is included. Clear photos of the serial label, the mode selection screen and the handpiece connector help a dealer confirm the unit.