Identity
- Trade Name
- MedX Rehab Tethered Laser FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 450 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628451918301 FDA UDI
- 510(k) Number
- K032231 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
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 Rehab Tethered Laser by MedX Health Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Musculoskeletal/physical therapy laser, professional.
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- Diode Laser System Deep Tissue Handpiece — Biolase, Inc. · Class II
- Dimed — Wuhan Dimed Laser Technology Co., Ltd. · Class II
Cleared under the same submission
K032231 also covers:
- MedX Rehab Console System — MedX Health Corp
- MedX Rehab Console System — MedX Health Corp
- MedX Rehab Console System — MedX Health Corp
- MedX Rehab Portable Laser — MedX Health Corp
- MedX Rehab Portable Laser — MedX Health Corp
- MedX Rehab Portable Laser — MedX Health Corp
- MedX SLD Light Cluster — MedX Health Corp
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 7bc1182e-d1a2-4b74-9f35-41648b74bd14 36 fields · synced Jun 6, 2026