Tranberg CLS Laser Fiber
K-Number: K151569 · 2016-02-12
ApplicantClinical Laserthermia Systems, AB
Decision Date2016-02-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Tranberg CLS Laser Fiber is a medical device manufactured by Clinical Laserthermia Systems, AB. It received FDA 510(k) clearance on 2016-02-12 under approval 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.
Frequently Asked Questions
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. It is manufactured by Clinical Laserthermia Systems, AB. The 510(k) number is K151569.
When was Tranberg CLS Laser Fiber approved by the FDA?
Tranberg CLS Laser Fiber received FDA 510(k) clearance on 2016-02-12, under approval number K151569.
What company makes Tranberg CLS Laser Fiber?
Tranberg CLS Laser Fiber is manufactured by Clinical Laserthermia Systems, AB.
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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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.