Jeisys Edge ONE

Edge ONE is a 10,600 nm carbon dioxide laser made by Jeisys Medical in Seoul. Jeisys's company history dates its launch to 2013, followed by FDA clearance in 2016, a European CE mark in 2017 and Japanese approval in 2018. The FDA clearance, K162169, names a 2010 system called the EDGE CO2 Laser System from JM System Co. as its main predicate and it clears Edge ONE for incision, excision, ablation, vaporization and coagulation of soft tissue in many specialties, and for ablative skin resurfacing with the scanning unit.

The 510(k) describes a console, two surgical handpieces and one fractional handpiece, a footswitch and accessories, with the beam delivered through an articulated arm. Output is 30 W, pulse duration 1 to 1000 ms, repetition rate 10 to 500 Hz and fractional pulse energy 1 to 300 mJ. The fractional scanner covers a 15 by 15 mm area with spot sizes of 120, 350 or 800 microns and a density setting from 0 to 42.4 percent. The surgical handpieces are listed at 0.15 and 1. Normal mode includes continuous, pulse, single pulse, repeat, group pulse and Ultra settings, and the laser is water cooled with a red 655 nm aiming beam.

In North America Jeisys now promotes Edge ONE under the EdgePolish name, which refers to a lighter treatment protocol on the same laser, not a different machine. Jeisys's own Grid RF/CO2 laser from 2009 and the earlier JM System EDGE are separate devices, so read the model name on the label.

On any CO2 laser the beam path is where buyers look first. Report the condition of the articulated arm, the mirrors and the scanner window, any loss of power the operator has noticed, and when the laser tube was last tested or replaced if you know. List both surgical handpieces and the fractional scanner, state the software version and supply voltage, and include service records.