FDA 510(k)

ECHOLASER X4

K-Number: K213594 · 2022-05-03

Decision Date2022-05-03

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ECHOLASER X4 is a medical device manufactured by Elesta S.P.A. It received FDA 510(k) clearance on 2022-05-03 under approval number K213594. 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 ECHOLASER X4?

ECHOLASER X4 is a medical device that received FDA 510(k) clearance on 2022-05-03. It is manufactured by Elesta S.P.A. The 510(k) number is K213594.

When was ECHOLASER X4 approved by the FDA?

ECHOLASER X4 received FDA 510(k) clearance on 2022-05-03, under approval number K213594.

What company makes ECHOLASER X4?

ECHOLASER X4 is manufactured by Elesta S.P.A.

What is the FDA product code for ECHOLASER X4?

The FDA product code for ECHOLASER X4 is GEX. This falls under the Gastroenterology category.

Other Devices by Elesta S.P.A

K230460Laser Thermal Therapy Kit K260632LASER THERMAL THERAPY KIT

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.