EdgeOne CO2 Laser
K-Number: K162169 · 2016-10-27
ApplicantJeisys Medical, Inc.
Decision Date2016-10-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
EdgeOne CO2 Laser is a medical device manufactured by Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2016-10-27 under approval number K162169. 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 EdgeOne CO2 Laser?
EdgeOne CO2 Laser is a medical device that received FDA 510(k) clearance on 2016-10-27. It is manufactured by Jeisys Medical, Inc.. The 510(k) number is K162169.
When was EdgeOne CO2 Laser approved by the FDA?
EdgeOne CO2 Laser received FDA 510(k) clearance on 2016-10-27, under approval number K162169.
What company makes EdgeOne CO2 Laser?
EdgeOne CO2 Laser is manufactured by Jeisys Medical, Inc..
What is the FDA product code for EdgeOne CO2 Laser?
The FDA product code for EdgeOne CO2 Laser 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.