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FDA 510(k)

CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE

K-Number: K083379 · 2008-12-12

ApplicantCynosure, Inc.
Decision Date2008-12-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 2008-12-12 under 510(k) number K083379. 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 CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE?

CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Cynosure, Inc.. The 510(k) number is K083379.

When did CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE receive FDA 510(k) clearance?

CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE received FDA 510(k) clearance on 2008-12-12, under 510(k) number K083379.

Who is the listed applicant for CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE?

The FDA 510(k) record lists Cynosure, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE?

The FDA product code for CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE 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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