Identity
- Trade Name
- MedX Rehab Portable Laser FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- The MedX Rehab Laser cluster, stand alone, LCS 450, is a battery powered laser medical device accessory and is part of MedX Health kit Item # 0915. The hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. ) This registration is to show the UDI for direct marking and primary packaging when this product shipped as a particular item, e.g. replacement or repaired unit, and not as a kit. FDA UDI
- Model / Reference
- LCS450 FDA UDI
- Description
- The MedX Rehab Laser cluster, stand alone, LCS 450, is a battery powered laser medical device accessory and is part of MedX Health kit Item # 0915. The hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. ) This registration is to show the UDI for direct marking and primary packaging when this product shipped as a particular item, e.g. replacement or repaired unit, and not as a kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628451918356 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 Portable Laser by MedX Health Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Tethered 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 ffb51ebe-ef60-4fca-8dbe-e9f89cd1b9ca 36 fields · synced May 30, 2026