Identity
- Trade Name
- MedX SLD Light Cluster FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MCT1000 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628451918332 FDA UDI
- 510(k) Number
- K050022 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Musculoskeletal/physical therapy laser, professional
MedX SLD Light Cluster 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
K050022 also covers:
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 2b268613-42d5-43c1-901b-1a1167f2b81c 36 fields · synced May 31, 2026