FDA 510(k)

Tranberg CLS Diffusor Laser Fiber

K-Number: K163103 · 2017-03-23

ApplicantClinical Laserthermia Systems, AB

Decision Date2017-03-23

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Tranberg CLS Diffusor Laser Fiber is a medical device manufactured by Clinical Laserthermia Systems, AB. It received FDA 510(k) clearance on 2017-03-23 under approval number K163103. 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.

Frequently Asked Questions

What is the Tranberg CLS Diffusor Laser Fiber?

Tranberg CLS Diffusor Laser Fiber is a medical device that received FDA 510(k) clearance on 2017-03-23. It is manufactured by Clinical Laserthermia Systems, AB. The 510(k) number is K163103.

When was Tranberg CLS Diffusor Laser Fiber approved by the FDA?

Tranberg CLS Diffusor Laser Fiber received FDA 510(k) clearance on 2017-03-23, under approval number K163103.

What company makes Tranberg CLS Diffusor Laser Fiber?

Tranberg CLS Diffusor Laser Fiber is manufactured by Clinical Laserthermia Systems, AB.

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

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

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Other Devices by Clinical Laserthermia Systems, AB

K151569Tranberg CLS Laser Fiber K201466Tranberg CLS Laser Applicator K214125TRANBERG Thermoguide Therapy System K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)

Related Devices (Code: GEX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.