ERISE Laser handpiece
K-Number: K202258 · 2021-04-26
ApplicantEl.En Electronic Engineering Spa
Decision Date2021-04-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ERISE Laser handpiece is a medical device manufactured by El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2021-04-26 under approval number K202258. 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 ERISE Laser handpiece?
ERISE Laser handpiece is a medical device that received FDA 510(k) clearance on 2021-04-26. It is manufactured by El.En Electronic Engineering Spa. The 510(k) number is K202258.
When was ERISE Laser handpiece approved by the FDA?
ERISE Laser handpiece received FDA 510(k) clearance on 2021-04-26, under approval number K202258.
What company makes ERISE Laser handpiece?
ERISE Laser handpiece is manufactured by El.En Electronic Engineering Spa.
What is the FDA product code for ERISE Laser handpiece?
The FDA product code for ERISE Laser handpiece is GEX. This falls under the Gastroenterology category.
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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.