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FDA 510(k)

POLARIS WR

K-Number: K031671 · 2003-12-01

ApplicantSyneron Medical, Ltd.
Decision Date2003-12-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLARIS WR 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 2003-12-01 under 510(k) number K031671. 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 WR?

POLARIS WR is a medical device that received FDA 510(k) clearance on 2003-12-01. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K031671.

When did POLARIS WR receive FDA 510(k) clearance?

POLARIS WR received FDA 510(k) clearance on 2003-12-01, under 510(k) number K031671.

Who is the listed applicant for POLARIS WR?

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 WR?

The FDA product code for POLARIS WR 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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