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FDA 510(k)

POLARIS LV, LVA APPLICATOR

K-Number: K052324 · 2005-09-14

ApplicantSyneron Medical, Ltd.
Decision Date2005-09-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLARIS LV, LVA APPLICATOR 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 2005-09-14 under 510(k) number K052324. 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 LV, LVA APPLICATOR?

POLARIS LV, LVA APPLICATOR is a medical device that received FDA 510(k) clearance on 2005-09-14. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K052324.

When did POLARIS LV, LVA APPLICATOR receive FDA 510(k) clearance?

POLARIS LV, LVA APPLICATOR received FDA 510(k) clearance on 2005-09-14, under 510(k) number K052324.

Who is the listed applicant for POLARIS LV, LVA APPLICATOR?

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 LV, LVA APPLICATOR?

The FDA product code for POLARIS LV, LVA APPLICATOR 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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