Home › EL.EN. SPA › DEKA SmartXide UltraSpeed 2
DEKA SmartXide UltraSpeed 2
EL.EN. SPA · Model M110F1 · UDI-DI 08057017760726
GEX
Prescription
1
510(k) clearances
43,846
Adverse events (107 deaths)
200
Recalls
485
Facilities
Description
DEKA SmartXide UltraSpeed 2 is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-05 | IPG Medical Corporation | Software anomaly that causes a false display of error code 5018. |
| 2026-02-27 | Olympus Corporation of the Americas | Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperabl |
| 2026-02-27 | Olympus Corporation of the Americas | Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperabl |
| 2026-01-27 | Lutronic Corporation | Reports of devices sparking/popping and potentially burning patients. |
| 2025-12-15 | LEASEIR TECHNOLOGIES SLU | The console label for affected devices is missing the "DANGER" symbol. |
| 2025-07-22 | LUMENIS, LTD. | The potential for unsterilized product within finished product labeled as sterile. |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.