Identity
- Trade Name
- XLR8 FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- MEDICAL - Handheld Low Level Laser - 2 diodes - 640nm 10mW - includes induction charger FDA UDI
- Model / Reference
- HLS FDA UDI
- Description
- MEDICAL - Handheld Low Level Laser - 2 diodes - 640nm 10mW - includes induction charger FDA UDI
Identifiers
- Catalog Number
- HLS FDA UDI
- Primary DI / UDI-DI
- 00858985006094 FDA UDI
- 510(k) Number
- K211186 FDA UDI
- FDA Product Code
- NHN 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
Yes
FDA UDI
Category: Musculoskeletal/physical therapy laser, professional
Xlr8 by Erchonia Corporation — 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
- Erchonia Corporation
Sources (1)
- FDA UDI 35cda0d8-305f-46fc-8697-ffab5d1bad2e 36 fields · synced Jun 9, 2026