Identity
- Trade Name
- MedX Oralase System FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 3122 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628451918264 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal/physical therapy laser, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Musculoskeletal/physical therapy laser, professional
MedX Oralase System by MedX Health Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MedX Health Corp
Sources (1)
- FDA UDI 8d4314ba-f1f5-431f-bd7d-283aedab5ab0 35 fields · synced May 30, 2026