FDA 510(k)

PicoWay Laser System

K-Number: K160607 · 2016-07-05

Decision Date2016-07-05

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 2016-07-05 under approval number K160607. 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 2016-07-05. It is manufactured by Syneron Candela Corporation. The 510(k) number is K160607.

When was PicoWay Laser System approved by the FDA?

PicoWay Laser System received FDA 510(k) clearance on 2016-07-05, under approval number K160607.

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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Related PubMed Literature

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Other Devices by Syneron Candela Corporation

K161043Profound System K153527PicoWay Laser System K170597PicoWay Laser System K162454PicoWay Laser System

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.