FDA Device Intelligence
Home › MedX Health Corp › MedX Rehab Portable Laser

MedX Rehab Portable Laser

MedX Health Corp · Model LCS450 · UDI-DI 00628451918356

ILY Prescription
1
510(k) clearances
294
Adverse events (4 deaths)
20
Recalls
498
Facilities

Description

The MedX Rehab Laser cluster, stand alone, LCS 450, is a battery powered laser medical device accessory and is part of MedX Health kit Item # 0915. The hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. ) This registration is to show the UDI for direct marking and primary packaging when this product shipped as a particular item, e.g. replacement or repaired unit, and not as a kit.

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.

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 keyRead 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.