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FDA 510(k)

POLRIS LV

K-Number: K030186 · 2003-04-14

ApplicantSyneron Medical, Ltd.
Decision Date2003-04-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLRIS LV 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 2003-04-14 under 510(k) number K030186. 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 POLRIS LV?

POLRIS LV is a medical device that received FDA 510(k) clearance on 2003-04-14. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K030186.

When did POLRIS LV receive FDA 510(k) clearance?

POLRIS LV received FDA 510(k) clearance on 2003-04-14, under 510(k) number K030186.

Who is the listed applicant for POLRIS LV?

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 POLRIS LV?

The FDA product code for POLRIS LV 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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