Home › MedX Health Corp › MedX Oralase Portable Laser
MedX Oralase Portable Laser
MedX Health Corp · Model 0910 · UDI-DI 00628451918202
ILY
Prescription
1
510(k) clearances
294
Adverse events (4 deaths)
20
Recalls
498
Facilities
Description
The Oralase Portable Portable Laser delivers high-quality laser & light therapy for Oralase applications.The laser can be used in a variety of procedures to reduce pain, swelling, bleeding, bruising and other conditions. The device features one GaAIAs near-infrared laser diode and three visible red guide LEDs that deliver laser & light therapy. The Oralase Portable Laser has been designed for licensed or certified healthcare professionals.
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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Get your free API keyRead the docsData 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.