Identity
- Trade Name
- ML 830® FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, home-use FDA UDI
- Device Name
- SL Triple Probe FDA UDI
- Model / Reference
- ML-830-07-001 FDA UDI
- Description
- SL Triple Probe FDA UDI
Identifiers
- Catalog Number
- ML-830-07-001 FDA UDI
- Primary DI / UDI-DI
- 00859626006268 FDA UDI
- 510(k) Number
- K010175 FDA UDI
- FDA Product Code
- NHN FDA UDI
- GMDN Term
- Musculoskeletal/physical therapy laser, home-use 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
No
FDA UDI
Over-the-Counter
Yes
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, home-use
Ml 830® by Microlight Corporation Of America — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K010175 also covers:
- ML 830® — MICROLIGHT CORPORATION OF AMERICA
- ML 830® — MICROLIGHT CORPORATION OF AMERICA
- ML 830® — MICROLIGHT CORPORATION OF AMERICA
- ML 830® — MICROLIGHT CORPORATION OF AMERICA
- ML 830® — MICROLIGHT CORPORATION OF AMERICA
- ML 830® — MICROLIGHT CORPORATION OF AMERICA
- ML 830® — MICROLIGHT CORPORATION OF AMERICA
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
- Microlight Corporation Of America
Sources (1)
- FDA UDI 83feb47c-d387-4665-8a43-71784d3d1e42 36 fields · synced Jun 8, 2026