GentleMax Pro Plus
K-Number: K201111 · 2020-05-26
ApplicantCandela Corporation
Decision Date2020-05-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
GentleMax Pro Plus is a medical device manufactured by Candela Corporation. It received FDA 510(k) clearance on 2020-05-26 under approval number K201111. 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 GentleMax Pro Plus?
GentleMax Pro Plus is a medical device that received FDA 510(k) clearance on 2020-05-26. It is manufactured by Candela Corporation. The 510(k) number is K201111.
When was GentleMax Pro Plus approved by the FDA?
GentleMax Pro Plus received FDA 510(k) clearance on 2020-05-26, under approval number K201111.
What company makes GentleMax Pro Plus?
GentleMax Pro Plus is manufactured by Candela Corporation.
What is the FDA product code for GentleMax Pro Plus?
The FDA product code for GentleMax Pro Plus 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.