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FDA 510(k)

DERMA YAG

K-Number: K062762 · 2007-03-01

ApplicantEl.En Electronic Engineering Spa
Decision Date2007-03-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMA YAG is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2007-03-01 under 510(k) number K062762. 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 DERMA YAG?

DERMA YAG is a medical device that received FDA 510(k) clearance on 2007-03-01. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K062762.

When did DERMA YAG receive FDA 510(k) clearance?

DERMA YAG received FDA 510(k) clearance on 2007-03-01, under 510(k) number K062762.

Who is the listed applicant for DERMA YAG?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMA YAG?

The FDA product code for DERMA YAG 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.

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