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Doctor Diode Laser

LAMBDA SPA · Model Doctor Smile · UDI-DI 08056093610109

GEX Prescription

510(k) clearances

44,262

Adverse events (107 deaths)

201

Recalls

487

Facilities

Description

Doctor Diode Laser Family including Doctor Smile Wiser is available with power of 14 W and is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Genitourinary, thoracic surgery, plastic surgery and dermatology, aesthetics including vascular lesions and hair removal, general surgery, ophthalmology, orthopedics, podiatry, arthroscopy, spinal surgery, gynecology, pulmonary surgery, neurosurgery, gastroenterology,head/neck/ENT and radiology, endovascular coagulation, oral surgery and dental procedures. The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items: – 08056093610024 Wiser Laser - 08056093611090 or 08056093611106 protective glasses - 08056093611120 and/or 08056093611137 handpieces - 08056093611113 and/or 08056093611007 and/or 08056093611045 and/or 08056093611038 and/or 08056093611014 and/or 08056093611021 tips

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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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.