Cellene CO2 Laser System
K-Number: K182270 · 2018-11-02
ApplicantBio-Med USA, Inc.
Decision Date2018-11-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Cellene CO2 Laser System is a medical device manufactured by Bio-Med USA, Inc.. It received FDA 510(k) clearance on 2018-11-02 under approval number K182270. 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 Cellene CO2 Laser System?
Cellene CO2 Laser System is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Bio-Med USA, Inc.. The 510(k) number is K182270.
When was Cellene CO2 Laser System approved by the FDA?
Cellene CO2 Laser System received FDA 510(k) clearance on 2018-11-02, under approval number K182270.
What company makes Cellene CO2 Laser System?
Cellene CO2 Laser System is manufactured by Bio-Med USA, Inc..
What is the FDA product code for Cellene CO2 Laser System?
The FDA product code for Cellene CO2 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.