Soli-Lite LG4 Galileo
K-Number: K192755 · 2019-12-20
ApplicantSilhouet-Tone Corporation
Decision Date2019-12-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Soli-Lite LG4 Galileo is a medical device manufactured by Silhouet-Tone Corporation. It received FDA 510(k) clearance on 2019-12-20 under approval number K192755. 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 Soli-Lite LG4 Galileo?
Soli-Lite LG4 Galileo is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Silhouet-Tone Corporation. The 510(k) number is K192755.
When was Soli-Lite LG4 Galileo approved by the FDA?
Soli-Lite LG4 Galileo received FDA 510(k) clearance on 2019-12-20, under approval number K192755.
What company makes Soli-Lite LG4 Galileo?
Soli-Lite LG4 Galileo is manufactured by Silhouet-Tone Corporation.
What is the FDA product code for Soli-Lite LG4 Galileo?
The FDA product code for Soli-Lite LG4 Galileo 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.