Address:1495 Bonhill Road,MISSISSAUGA Ontario,CA
Device Description : The MedX Oralase Console system is a therapeutic Low-Level Laser and Light ther The MedX Oralase Console system is a therapeutic Low-Level Laser and Light therapy system for Oralase application. It features a handheld laser device, tethered to a console, which provides low level laser therapy to a smaller focused treatment area. The single near-infra-red laser diode tip has a visible LED guide light for pinpoint application. The MedX 1100N console powers the handheld laser therapy device.
Device Class :
Duns Number: 202128257
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MedX Rehab Console 1100N controls and powers the MedX tethered laser medical The MedX Rehab Console 1100N controls and powers the MedX tethered laser medical device accessories like the Multi-cluster, tethered MCT1001, Laser cluster, tethered LCT450 and Laser probe, tethered LPT 201. It is the main reference for identification and traceability, and part of the kit for MedX Health Item numbers #3110, #3114, #3116, #3120, and #3122. 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.
Device Class :
Duns Number: 202128257
Premarket Exempt : No
Prescription Use : No
Device Description : The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for bro 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.
Device Class :
Duns Number: 202128257
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is a hand-held Low Level Laser and light Therapy (LLLT) device for use to treat a wide variety of medical conditions. It is also used for treating deeper tissue conditions. This accessory contains three SLD near-infrared laser light diodes for therapeutic applications and a visible LED guide light. It is part of the kit for MedX Health Items #3114, #3116.LCT 450 is controlled and powered by MedX Rehab console 1100N. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
Device Class :
Duns Number: 202128257
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MedX Health portable-tethered laser medical device or LPT201 is part of the The MedX Health portable-tethered laser medical device or LPT201 is part of the kit for MedX Health item numbers #3120 and #3122. It is controlled and powered by MedX Rehab Console MBM1100N. This product is registered for the purpose showing its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
Device Class : 2
Duns Number: 202128257
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MedX Home console or MBM 2030 controls and provides power to MedX SLD cluste The MedX Home console or MBM 2030 controls and provides power to MedX SLD cluster MCT 1000. It is the main reference for identification and traceability, and part of the kit for MedX item number #2130. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
Device Class : 2
Duns Number: 202128257
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MedX SLD Light diode Cluster is used together with the MedX Home console to The MedX SLD Light diode Cluster is used together with the MedX Home console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated.
Device Class :
Duns Number: 202128257
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Oralase Portable Laser, LPS200, delivers high-quality laser & light therapy The Oralase Portable Laser, LPS200, 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. This device is the main reference for identification and traceability for MedX Health kit Item# 0910 This product is registered to show its UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
Device Class : 2
Duns Number: 202128257
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MedX Rehab Laser cluster, stand alone, LCS 450, is a battery powered laser m 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.
Device Class :
Duns Number: 202128257
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quali The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, 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. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals.This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.
Device Class :
Duns Number: 202128257
Premarket Exempt : No
Prescription Use : Yes