Identity
- Trade Name
- Instructions for Use Laser applicator - US FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Model / Reference
- L-2018-060 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17340007000734 FDA UDI
- 510(k) Number
- K201466 FDA UDI
- FDA Product Code
- GEX 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General/multiple surgical laser system beam guide, reusable
Instructions for Use Laser applicator - 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 laser system beam guide, reusable.
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- ProFlex — INNOVAQUARTZ LLC · Class II
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- ProFlex™ — INNOVAQUARTZ LLC · Class II
Cleared under the same submission
K201466 also covers:
- Laser Applicator Non-cooled — 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
- Laser Applicator Non-cooled — Clinical Laserthermia Systems AB
- Laser Applicator Non-cooled — Clinical Laserthermia Systems AB
- MR Catheter — Clinical Laserthermia Systems AB
- MR Catheter — Clinical Laserthermia Systems AB
- MR Stylet — Clinical Laserthermia Systems AB
- MR Stylet — Clinical Laserthermia Systems AB
- MR Stylet — 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 e74438d0-2c48-4584-9a4f-067d9ef4da42 33 fields · synced Jun 8, 2026