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Tranberg CLS Laser Applicator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201466

by Clinical Laserthermia Systems Ab

Identifiers

510(k) Number
K201466 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tranberg CLS Laser Applicator is a non-cooled laser applicator designed for use in thermal therapy procedures. It is part of the TRANBERG® Thermal Therapy System and utilizes unique fiber technology to optimize heat distribution in tissue during ablation.

The device is supplied as a non-cooled 15 Gauge laser applicator for various ablation sizes and shapes. It is intended for use by medical professionals only and has been determined to be substantially equivalent to a predicate device under FDA 510(k) clearance K201466 with product code GEX.

Frequently asked questions

What is the Tranberg CLS Laser Applicator used for?

The Tranberg CLS Laser Applicator is designed for use in thermal therapy procedures, specifically for ablation, utilizing unique fiber technology to optimize heat distribution in tissue during treatment.

How is the Tranberg CLS Laser Applicator supplied and what is its gauge size?

The device is supplied as a non-cooled laser applicator with a 15 Gauge size, intended for various ablation sizes and shapes in clinical thermal therapy applications.

Is the Tranberg CLS Laser Applicator intended for single-use or reuse?

The device is supplied as a non-cooled laser applicator for professional use, and based on its description as a supplied component of a thermal therapy system, it is intended for single-use to ensure sterility and performance in ablation procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TRANBERG® Thermal Therapy System - CLS, PDF Clinical Laserthermia Systems, AB ℅ David Makanani, TRANBERG® Laser Applicators and Introducers - CLS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Clinical Laserthermia Systems Ab
FDA Applicant
Clinical Laserthermia Systems, AB

Sources (1)

  • FDA 510(k) K201466 24 fields · synced Oct 1, 2026