Tranberg CLS Laser Applicator
K-Number: K201466 · 2021-03-26
ApplicantClinical Laserthermia Systems, AB
Decision Date2021-03-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Tranberg CLS Laser Applicator is a medical device manufactured by Clinical Laserthermia Systems, AB. It received FDA 510(k) clearance on 2021-03-26 under approval number K201466. 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 Applicator?
Tranberg CLS Laser Applicator is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Clinical Laserthermia Systems, AB. The 510(k) number is K201466.
When was Tranberg CLS Laser Applicator approved by the FDA?
Tranberg CLS Laser Applicator received FDA 510(k) clearance on 2021-03-26, under approval number K201466.
What company makes Tranberg CLS Laser Applicator?
Tranberg CLS Laser Applicator is manufactured by Clinical Laserthermia Systems, AB.
What is the FDA product code for Tranberg CLS Laser Applicator?
The FDA product code for Tranberg CLS Laser Applicator 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.