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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 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 2017-03-23 under 510(k) 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. The listed applicant is Clinical Laserthermia Systems, AB. The 510(k) number is K163103.

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

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

Who is the listed applicant for Tranberg CLS Diffusor 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 Diffusor Laser Fiber?

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

Other records listing Clinical Laserthermia Systems, AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)K214125TRANBERG Thermoguide Therapy SystemK201466Tranberg CLS Laser ApplicatorK151569Tranberg CLS Laser Fiber

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

Official Source

View on FDA Database →

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

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