Sterling 5W Diode Laser
K-Number: K160413 · 2016-09-21
ApplicantCAO Group, Inc.
Decision Date2016-09-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Sterling 5W Diode Laser is a medical device manufactured by CAO Group, Inc.. It received FDA 510(k) clearance on 2016-09-21 under approval number K160413. 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 5W Diode Laser?
Sterling 5W Diode Laser is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by CAO Group, Inc.. The 510(k) number is K160413.
When was Sterling 5W Diode Laser approved by the FDA?
Sterling 5W Diode Laser received FDA 510(k) clearance on 2016-09-21, under approval number K160413.
What company makes Sterling 5W Diode Laser?
Sterling 5W Diode Laser is manufactured by CAO Group, Inc..
What is the FDA product code for Sterling 5W Diode Laser?
The FDA product code for Sterling 5W 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.