PALLAS 308/311 Solid-State UV Laser System
K-Number: K191501 · 2020-01-03
ApplicantLaseroptek Co., Ltd.
Decision Date2020-01-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PALLAS 308/311 Solid-State UV Laser System is a medical device manufactured by Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2020-01-03 under approval number K191501. 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 PALLAS 308/311 Solid-State UV Laser System?
PALLAS 308/311 Solid-State UV Laser System is a medical device that received FDA 510(k) clearance on 2020-01-03. It is manufactured by Laseroptek Co., Ltd.. The 510(k) number is K191501.
When was PALLAS 308/311 Solid-State UV Laser System approved by the FDA?
PALLAS 308/311 Solid-State UV Laser System received FDA 510(k) clearance on 2020-01-03, under approval number K191501.
What company makes PALLAS 308/311 Solid-State UV Laser System?
PALLAS 308/311 Solid-State UV Laser System is manufactured by Laseroptek Co., Ltd..
What is the FDA product code for PALLAS 308/311 Solid-State UV Laser System?
The FDA product code for PALLAS 308/311 Solid-State UV Laser System 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.