PicoWay Laser System
K-Number: K153527 · 2016-03-02
ApplicantSyneron Candela Corporation
Decision Date2016-03-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PicoWay Laser System is a medical device manufactured by Syneron Candela Corporation. It received FDA 510(k) clearance on 2016-03-02 under approval number K153527. 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 PicoWay Laser System?
PicoWay Laser System is a medical device that received FDA 510(k) clearance on 2016-03-02. It is manufactured by Syneron Candela Corporation. The 510(k) number is K153527.
When was PicoWay Laser System approved by the FDA?
PicoWay Laser System received FDA 510(k) clearance on 2016-03-02, under approval number K153527.
What company makes PicoWay Laser System?
PicoWay Laser System is manufactured by Syneron Candela Corporation.
What is the FDA product code for PicoWay Laser System?
The FDA product code for PicoWay Laser System 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.