Helios III
K-Number: K152856 · 2016-06-02
ApplicantLaseroptek Co., Ltd.
Decision Date2016-06-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Helios III is a medical device manufactured by Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2016-06-02 under approval number K152856. 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 Helios III?
Helios III is a medical device that received FDA 510(k) clearance on 2016-06-02. It is manufactured by Laseroptek Co., Ltd.. The 510(k) number is K152856.
When was Helios III approved by the FDA?
Helios III received FDA 510(k) clearance on 2016-06-02, under approval number K152856.
What company makes Helios III?
Helios III is manufactured by Laseroptek Co., Ltd..
What is the FDA product code for Helios III?
The FDA product code for Helios III is GEX. This falls under the Gastroenterology category.
Other Devices by Laseroptek 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.