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SYMPHONY

DEKA M.E.L.A. SRL · Model M126AB1 · UDI-DI 08034108512532

GEX Prescription

510(k) clearances

43,846

Adverse events (107 deaths)

200

Recalls

485

Facilities

Description

The DEKA AGAIN PRO family is a medical laser family equipped with Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user repleaceable optical fiber with a wider range of intercheangeable, quick release laser handpieces with electronic spot recognition.

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

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Data 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.