US 450 Diode Laser Equipment
K-Number: K222916 · 2022-12-09
Decision Date2022-12-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
US 450 Diode Laser Equipment is a medical device manufactured by Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2022-12-09 under approval number K222916. 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 US 450 Diode Laser Equipment?
US 450 Diode Laser Equipment is a medical device that received FDA 510(k) clearance on 2022-12-09. It is manufactured by Beijing Globalipl Development Co., Ltd.. The 510(k) number is K222916.
When was US 450 Diode Laser Equipment approved by the FDA?
US 450 Diode Laser Equipment received FDA 510(k) clearance on 2022-12-09, under approval number K222916.
What company makes US 450 Diode Laser Equipment?
US 450 Diode Laser Equipment is manufactured by Beijing Globalipl Development Co., Ltd..
What is the FDA product code for US 450 Diode Laser Equipment?
The FDA product code for US 450 Diode Laser Equipment 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.