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FDA 510(k)

EMATRIX CO2

K-Number: K101321 · 2010-11-09

ApplicantSyneron Medical, Ltd.
Decision Date2010-11-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EMATRIX CO2 is the device name listed in this FDA 510(k) record. The listed applicant is Syneron Medical, Ltd.. It received FDA 510(k) clearance on 2010-11-09 under 510(k) number K101321. 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 EMATRIX CO2?

EMATRIX CO2 is a medical device that received FDA 510(k) clearance on 2010-11-09. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K101321.

When did EMATRIX CO2 receive FDA 510(k) clearance?

EMATRIX CO2 received FDA 510(k) clearance on 2010-11-09, under 510(k) number K101321.

Who is the listed applicant for EMATRIX CO2?

The FDA 510(k) record lists Syneron Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMATRIX CO2?

The FDA product code for EMATRIX CO2 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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