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FDA 510(k)

POLARIS WR, ST APPLICATOR

K-Number: K053616 · 2006-03-14

ApplicantSyneron Medical, Ltd.
Decision Date2006-03-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLARIS WR, ST 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 2006-03-14 under 510(k) number K053616. 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, ST APPLICATOR?

POLARIS WR, ST APPLICATOR is a medical device that received FDA 510(k) clearance on 2006-03-14. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K053616.

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

POLARIS WR, ST APPLICATOR received FDA 510(k) clearance on 2006-03-14, under 510(k) number K053616.

Who is the listed applicant for POLARIS WR, ST 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 WR, ST APPLICATOR?

The FDA product code for POLARIS WR, ST 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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