PicoSure Workstation
K-Number: K160480 · 2016-05-17
ApplicantCynosure, Inc.
Decision Date2016-05-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PicoSure Workstation is a medical device manufactured by Cynosure, Inc.. It received FDA 510(k) clearance on 2016-05-17 under approval number K160480. 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 PicoSure Workstation?
PicoSure Workstation is a medical device that received FDA 510(k) clearance on 2016-05-17. It is manufactured by Cynosure, Inc.. The 510(k) number is K160480.
When was PicoSure Workstation approved by the FDA?
PicoSure Workstation received FDA 510(k) clearance on 2016-05-17, under approval number K160480.
What company makes PicoSure Workstation?
PicoSure Workstation is manufactured by Cynosure, Inc..
What is the FDA product code for PicoSure Workstation?
The FDA product code for PicoSure Workstation 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.