HELIOS IV 785
K-Number: K212663 · 2022-06-09
ApplicantLaseroptek Co., Ltd.
Decision Date2022-06-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
HELIOS IV 785 is a medical device manufactured by Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2022-06-09 under approval number K212663. 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 IV 785?
HELIOS IV 785 is a medical device that received FDA 510(k) clearance on 2022-06-09. It is manufactured by Laseroptek Co., Ltd.. The 510(k) number is K212663.
When was HELIOS IV 785 approved by the FDA?
HELIOS IV 785 received FDA 510(k) clearance on 2022-06-09, under approval number K212663.
What company makes HELIOS IV 785?
HELIOS IV 785 is manufactured by Laseroptek Co., Ltd..
What is the FDA product code for HELIOS IV 785?
The FDA product code for HELIOS IV 785 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.