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FDA 510(k)

POLARIS DS/COMET

K-Number: K041959 · 2004-11-08

ApplicantSyneron Medical, Ltd.
Decision Date2004-11-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLARIS DS/COMET 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 2004-11-08 under 510(k) number K041959. 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 POLARIS DS/COMET?

POLARIS DS/COMET is a medical device that received FDA 510(k) clearance on 2004-11-08. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K041959.

When did POLARIS DS/COMET receive FDA 510(k) clearance?

POLARIS DS/COMET received FDA 510(k) clearance on 2004-11-08, under 510(k) number K041959.

Who is the listed applicant for POLARIS DS/COMET?

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 POLARIS DS/COMET?

The FDA product code for POLARIS DS/COMET 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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