Identity
- Trade Name
- Mains Cable US FDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Model / Reference
- 4001-03 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17340007000130 FDA UDI
- 510(k) Number
- K142216 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General/multiple surgical diode laser system
Mains Cable US by Clinical Laserthermia Systems AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical diode laser system.
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- Epic S-Series Diode Laser System — Biolase, Inc. · Class II
Cleared under the same submission
K142216 also covers:
- Foot Pedal — Clinical Laserthermia Systems AB
- Laser Warning Sign — Clinical Laserthermia Systems AB
- Mobile Laser Unit — Clinical Laserthermia Systems AB
- Mobile Laser Unit — Clinical Laserthermia Systems AB
- Protection Goggles — Clinical Laserthermia Systems AB
- Thermal Therapy System Instructions for Use — Clinical Laserthermia Systems AB
- Tissue Temp Probe — Clinical Laserthermia Systems AB
- Tissue Temp Probe — Clinical Laserthermia Systems AB
- Tissue Temp Probe — Clinical Laserthermia Systems AB
- Tissue Temp Probe — Clinical Laserthermia Systems AB
- Tissue Temp Probe — Clinical Laserthermia Systems AB
- Tissue Temp Probe — Clinical Laserthermia Systems AB
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
- Clinical Laserthermia Systems AB
Sources (1)
- FDA UDI 517f06fe-3db4-423e-a084-757117357387 33 fields · synced Jun 6, 2026