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FDA 510(k)

MODIFICATION TO AURORA DS

K-Number: K033586 · 2003-12-10

ApplicantSyneron Medical, Ltd.
Decision Date2003-12-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO AURORA DS 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 2003-12-10 under 510(k) number K033586. 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 MODIFICATION TO AURORA DS?

MODIFICATION TO AURORA DS is a medical device that received FDA 510(k) clearance on 2003-12-10. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K033586.

When did MODIFICATION TO AURORA DS receive FDA 510(k) clearance?

MODIFICATION TO AURORA DS received FDA 510(k) clearance on 2003-12-10, under 510(k) number K033586.

Who is the listed applicant for MODIFICATION TO AURORA DS?

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 MODIFICATION TO AURORA DS?

The FDA product code for MODIFICATION TO AURORA DS 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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