Lotus III Multi-Pulsed Er: Yag Laser System
K-Number: K182045 · 2018-12-27
ApplicantLaseroptek Co., Ltd.
Decision Date2018-12-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Lotus III Multi-Pulsed Er: Yag Laser System is a medical device manufactured by Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2018-12-27 under approval number K182045. 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 Lotus III Multi-Pulsed Er: Yag Laser System?
Lotus III Multi-Pulsed Er: Yag Laser System is a medical device that received FDA 510(k) clearance on 2018-12-27. It is manufactured by Laseroptek Co., Ltd.. The 510(k) number is K182045.
When was Lotus III Multi-Pulsed Er: Yag Laser System approved by the FDA?
Lotus III Multi-Pulsed Er: Yag Laser System received FDA 510(k) clearance on 2018-12-27, under approval number K182045.
What company makes Lotus III Multi-Pulsed Er: Yag Laser System?
Lotus III Multi-Pulsed Er: Yag Laser System is manufactured by Laseroptek Co., Ltd..
What is the FDA product code for Lotus III Multi-Pulsed Er: Yag Laser System?
The FDA product code for Lotus III Multi-Pulsed Er: Yag 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.