Home › Canadian Pioneer Medical Technology Corporation › TORLASE-Alexandrite and Nd: Yag laser

TORLASE-Alexandrite and Nd: Yag laser

Canadian Pioneer Medical Technology Corporation · Model TORLASE · UDI-DI 00199284747210

GEX Prescription

510(k) clearances

44,035

Adverse events (107 deaths)

201

Recalls

489

Facilities

Description

TORLASE is a dual-wavelength long-pulse laser system combining Alexandrite (755 nm) and Nd:YAG (1064 nm) technologies for advanced aesthetic applications. It is designed for permanent hair reduction on all skin types, including tanned and dark skin. TORLASE effectively treats benign pigmented lesions, facial and leg veins, vascular lesions, angiomas, hemangiomas, venous lakes, and port wine stains. It also provides skin rejuvenation, diffuse redness reduction, wrinkle reduction, and PFB (pseudofolliculitis barbae) treatment. The system features adjustable spot sizes, high-tech skin cooling, and customizable treatment parameters to optimize safety and clinical outcomes. TORLASE is suitable for dermatology clinics, aesthetic centers, and medical spas, and complies with applicable medical device standards.

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

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 key Read the docs

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.