Lucid Q-PTP / HWA 55
K-Number: K161670 · 2016-11-02
ApplicantBison Medical Co, Ltd.
Decision Date2016-11-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Lucid Q-PTP / HWA 55 is a medical device manufactured by Bison Medical Co, Ltd.. It received FDA 510(k) clearance on 2016-11-02 under approval number K161670. 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 Lucid Q-PTP / HWA 55?
Lucid Q-PTP / HWA 55 is a medical device that received FDA 510(k) clearance on 2016-11-02. It is manufactured by Bison Medical Co, Ltd.. The 510(k) number is K161670.
When was Lucid Q-PTP / HWA 55 approved by the FDA?
Lucid Q-PTP / HWA 55 received FDA 510(k) clearance on 2016-11-02, under approval number K161670.
What company makes Lucid Q-PTP / HWA 55?
Lucid Q-PTP / HWA 55 is manufactured by Bison Medical Co, Ltd..
What is the FDA product code for Lucid Q-PTP / HWA 55?
The FDA product code for Lucid Q-PTP / HWA 55 is GEX. This falls under the Gastroenterology category.
Other Devices by Bison Medical Co, Ltd.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.