FDA 510(k)

Tranberg CLS Laser Fiber

Número K: K151569 · 2016-02-12

RequerenteClinical Laserthermia Systems, AB

Data da decisão2016-02-12

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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Outros registros que listam Clinical Laserthermia Systems, AB como candidato(a)

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