Identity
- Trade Name
- MR Introducer FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Model / Reference
- 4013-N6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17340007000956 FDA UDI
- 510(k) Number
- K214125 FDA UDI
- FDA Product Code
- ONO FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, reusable 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: General/multiple surgical laser system beam guide, reusable
MR Introducer by Clinical Laserthermia Systems AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical laser system beam guide, reusable.
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- Accu-Beam — Transamerican Technologies International · Class II
- Flex-G Laser Fiber with Extended Length Sheath — OPTICAL INTEGRITY, INC. · Class II
- ProFlex — INNOVAQUARTZ LLC · Class II
- Q-Lase™ Side-Firing Laser Fiber with SMA Connector — OPTICAL INTEGRITY, INC. · Class II
- Twister — WISDOM MEDICAL TECHNOLOGY, LLC · Class II
- ProFlex™ — INNOVAQUARTZ LLC · Class II
Cleared under the same submission
K214125 also covers:
- Instructions for Use Laser applicator - Neuro — Clinical Laserthermia Systems AB
- Instructions for use Tranberg Thermoguide Therapy System - US — Clinical Laserthermia Systems AB
- Laser Applicator Non-cooled — Clinical Laserthermia Systems AB
- Laser Applicator Non-cooled — Clinical Laserthermia Systems AB
- Laser Applicator Non-cooled — Clinical Laserthermia Systems AB
- Mobile Laser Unit — Clinical Laserthermia Systems AB
- Thermoguide Workstation — 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 f07cb9d6-9009-4674-b1c5-77a1eccf45bd 34 fields · synced May 30, 2026