Secret Duo
K-Number: K202043 · 2021-04-23
ApplicantIlooda Co,., Ltd.
Decision Date2021-04-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Secret Duo is a medical device manufactured by Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2021-04-23 under approval number K202043. 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 Secret Duo?
Secret Duo is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by Ilooda Co,., Ltd.. The 510(k) number is K202043.
When was Secret Duo approved by the FDA?
Secret Duo received FDA 510(k) clearance on 2021-04-23, under approval number K202043.
What company makes Secret Duo?
Secret Duo is manufactured by Ilooda Co,., Ltd..
What is the FDA product code for Secret Duo?
The FDA product code for Secret Duo is GEX. This falls under the Gastroenterology category.
Other Devices by Ilooda 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.