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Laser Engineering
LASER ENGINEERING · Model HWG305 · UDI-DI 00866988000285
GEX
Prescription
10
510(k) clearances
44,035
Adverse events (107 deaths)
201
Recalls
489
Facilities
Description
This device is an internally coated fusee silica waveguide used to deliver CO2 laser energy to the patient.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-06 | Lutronic Corporation | Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn. |
| 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 |
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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.