Sterling Supreme Diode Laser
K-Number: K181614 · 2019-09-10
ApplicantCAO Group, Inc.
Decision Date2019-09-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Sterling Supreme Diode Laser is a medical device manufactured by CAO Group, Inc.. It received FDA 510(k) clearance on 2019-09-10 under approval number K181614. 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 Sterling Supreme Diode Laser?
Sterling Supreme Diode Laser is a medical device that received FDA 510(k) clearance on 2019-09-10. It is manufactured by CAO Group, Inc.. The 510(k) number is K181614.
When was Sterling Supreme Diode Laser approved by the FDA?
Sterling Supreme Diode Laser received FDA 510(k) clearance on 2019-09-10, under approval number K181614.
What company makes Sterling Supreme Diode Laser?
Sterling Supreme Diode Laser is manufactured by CAO Group, Inc..
What is the FDA product code for Sterling Supreme Diode Laser?
The FDA product code for Sterling Supreme Diode 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.