Pioneer Elite Diode Laser
K-Number: K181602 · 2019-09-10
ApplicantCAO Group, Inc.
Decision Date2019-09-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Pioneer Elite Diode Laser is a medical device manufactured by CAO Group, Inc.. It received FDA 510(k) clearance on 2019-09-10 under approval number K181602. 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 Pioneer Elite Diode Laser?
Pioneer Elite 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 K181602.
When was Pioneer Elite Diode Laser approved by the FDA?
Pioneer Elite Diode Laser received FDA 510(k) clearance on 2019-09-10, under approval number K181602.
What company makes Pioneer Elite Diode Laser?
Pioneer Elite Diode Laser is manufactured by CAO Group, Inc..
What is the FDA product code for Pioneer Elite Diode Laser?
The FDA product code for Pioneer Elite 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.