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Doctor Smile

LAMBDA SPA · Model Doctor Smile B-980 · UDI-DI 08056093610093

GEX Prescription

510(k) clearances

44,260

Adverse events (107 deaths)

201

Recalls

489

Facilities

Description

Doctor Smile B-980 Laser is a standard diode medical laser with 980 nm wavelength. It is intended for use in the following procedure: surgical applications requiring the ablation, vaporization, excision, incision, haemostasis, or coagulation of soft tissue in medical specialties including dentistry, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics. The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items: 08056093610062 – B-980 Laser 08056093611090 - protective glasses 08056093611120 and/or 08056093611137 handpieces 08056093611083 and/or 08056093611052 and/or 08056093611069 and/or 08056093611076 fibers

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.