DEVICE: MedX Oralase System (00628451918264)
Device Identifier (DI) Information
MedX Oralase System
3122
In Commercial Distribution
MedX Health Corp
3122
In Commercial Distribution
MedX Health Corp
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 Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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60409 | Musculoskeletal/physical therapy laser, professional |
An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.
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FDA Product Code
[?]Product Code | Product Code Name |
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ILY | Lamp, Infrared, Therapeutic Heating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -4 and 149 Degrees Fahrenheit |
Handling Environment Humidity: between 20 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8d4314ba-f1f5-431f-bd7d-283aedab5ab0
December 08, 2022
7
December 27, 2017
December 08, 2022
7
December 27, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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50628451918269 | 5 | 00628451918264 | In Commercial Distribution | shipping carton box | |
30628451918265 | 3 | 00628451918264 | In Commercial Distribution | shipping carton box | |
20628451918268 | 2 | 00628451918264 | In Commercial Distribution | shipping carton box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1 905 670 4428
tobillo@medxhealth.com
tobillo@medxhealth.com