FDA 510(k)

Tranberg CLS Laser Fiber

N.º K: K151569 · 2016-02-12

SolicitanteClinical Laserthermia Systems, AB

Fecha de decisión2016-02-12

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tranberg CLS Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Laserthermia Systems, AB. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K151569. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tranberg CLS Laser Fiber?

Tranberg CLS Laser Fiber is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Clinical Laserthermia Systems, AB. The 510(k) number is K151569.

When did Tranberg CLS Laser Fiber receive FDA 510(k) clearance?

Tranberg CLS Laser Fiber received FDA 510(k) clearance on 2016-02-12, under 510(k) number K151569.

Who is the listed applicant for Tranberg CLS Laser Fiber?

The FDA 510(k) record lists Clinical Laserthermia Systems, AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tranberg CLS Laser Fiber?

The FDA product code for Tranberg CLS Laser Fiber is GEX. This falls under the Gastroenterology category.

Ensayos clínicos relacionados

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Otros registros que enlistan a Clinical Laserthermia Systems, AB como solicitante

K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)K214125TRANBERG Thermoguide Therapy System K201466Tranberg CLS Laser Applicator K163103Tranberg CLS Diffusor Laser Fiber

Dispositivos relacionados (Código: GEX)

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Fuente oficial

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