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Trolley

FDA UDI

Class II (US FDA UDI)

by Clinical Laserthermia Systems AB

Identity

Trade Name
Trolley FDA UDI
Generic Name
General/multiple surgical diode laser system FDA UDI
Model / Reference
4009-01 FDA UDI

Identifiers

Primary DI / UDI-DI
17340007000161 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
Not 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

No

FDA UDI

Trolley by Clinical Laserthermia Systems AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K142216 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clinical Laserthermia Systems AB

Sources (1)

  • FDA UDI a379b0e8-9d8e-41d7-a734-09c9cc8f9f8e 34 fields · synced May 30, 2026