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M-Hi D US

ASA SRL · Model F9000303 · UDI-DI 08033765391740

ILY

510(k) clearances

291

Adverse events (4 deaths)

Recalls

491

Facilities

Description

The M-Hi D US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.

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.