DEKA SmartXide PRO

The SmartXide PRO is a 10,600 nm carbon dioxide laser built by DEKA M.E.L.A. in Calenzano, Italy, and submitted to the FDA by its parent company El.En. It was cleared as a Special 510(k), K240537, on March 20, 2024, as a modified version of the earlier SmartXide with DOT scanner (K072159). The summary lists the changes as a restyled chassis and covers, revised dimensions and weight, a new CPU and graphical interface, and a restyled HiScan DOT scanning unit.

The FDA comparison table lists 30 W of maximum power, focusing handpieces with 0.2 and 0.4 mm spots, pulse widths from 1 to 80 ms, repetition rates from 5 to 100 Hz, and a 635 nm aiming beam. The HiScan DOT scanner attaches to the articulated arm and is cleared for ablative skin resurfacing, either fractional or full surface. Without the scanner, the clearance covers incision, excision, ablation, vaporization and coagulation of soft tissue in dermatology and plastic surgery, ENT, gynecology, neurosurgery, dental and oral surgery, and genitourinary surgery. DEKA's product page adds SmartPulse emission and up to five SmartStack levels for setting vaporization depth.

Several DEKA CO2 consoles carry the SmartXide name, so the exact model matters. The Tetra PRO clearance lists the SmartXide Punto at 50 W and the SmartXide Touch at 60 W. The Tetra PRO itself runs at 40 W with its own PSD pulse modes. An older SmartXide DOT has the same 30 W rating and scanner concept as the PRO but the earlier cabinet and interface. The rating label is the most reliable way to tell them apart.

When you list a SmartXide PRO, say whether the HiScan DOT scanner is included and working, and name every focusing handpiece. Buyers will ask about the condition of the articulated arm, the software version shown at startup, and the service history of the CO2 source, including any source replacement.