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MedX SLD Light Cluster

MedX Health Corp · Model 1001 · UDI-DI 00628451918295

ILY Prescription

510(k) clearances

294

Adverse events (4 deaths)

Recalls

504

Facilities

Description

The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for broader applications. This accessory can be strapped to the body for “hands-free”, unattended treatment. The accessory contains a large number of Light emitting diodes that are used to treat a variety of medical conditions such as swelling, inflammation, pain, bruising, wound healing and many other medical conditions. This laser medical device accessory is controlled and powered by MBM 1100N. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.

Recalls

Date	Firm	Reason
2026-01-09	Technological Medical Advancements LLC	Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthri
2025-07-24	THOR Photomedicine Ltd	The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
2025-07-24	THOR Photomedicine Ltd	The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
2025-07-24	THOR Photomedicine Ltd	The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
2025-07-24	THOR Photomedicine Ltd	The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
2025-02-12	MITO RED LIGHT INC	The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
2023-11-20	THOR Photomedicine Ltd	One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or
2022-09-13	Thor Photomedicine Ltd	Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
2022-09-13	Thor Photomedicine Ltd	Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
2022-09-13	Thor Photomedicine Ltd	Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

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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.