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Laserneedle Touch

Laserneedle GmbH · Model 12000-Trolley · UDI-DI 04260649160046

ILY
10
510(k) clearances
292
Adverse events (4 deaths)
20
Recalls
494
Facilities

Description

Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Product number: 35000 Primary DI number: 4260649160213) - Laser protection goggles (Product number: 32010 Primary DI number: 4260649160305) - LN Tape (Product number: 40100 Primary DI number: 4260649160466) - Self adhesive applicator (Product number: 40510 Primary DI number: 4260649160404) - LN Tip caps (Product number: 40710 Primary DI number: 4260649160503) - Set of silicon pads (Product number: 40600; Primary DI number: 4260649160312) - Silicone applicators (Product number: 40410; Primary DI number: 4260649160411)

Recalls

DateFirmReason
2026-01-09Technological Medical Advancements LLCSoftware 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
2025-07-24THOR Photomedicine LtdThe 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.
2025-07-24THOR Photomedicine LtdThe 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.
2025-07-24THOR Photomedicine LtdThe 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.
2025-07-24THOR Photomedicine LtdThe 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.
2025-02-12MITO RED LIGHT INCThe near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
2023-11-20THOR Photomedicine LtdOne 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
2022-09-13Thor Photomedicine LtdFailure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
2022-09-13Thor Photomedicine LtdFailure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
2022-09-13Thor Photomedicine LtdFailure 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.