Identity
- Trade Name
- MedX Oralase Portable Laser FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 0910 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628451918202 FDA UDI
- 510(k) Number
- K082707 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
No
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 Portable Laser by MedX Health Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 d675422a-719c-4874-b1d8-56f4b2095b3e 36 fields · synced May 30, 2026