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FDA 510(k)

ELITE MPX LASER SYSTEM WITH CRYO C

K-Number: K091169 · 2009-05-13

ApplicantCynosure, Inc.
Decision Date2009-05-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELITE MPX LASER SYSTEM WITH CRYO C is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 2009-05-13 under 510(k) number K091169. 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 ELITE MPX LASER SYSTEM WITH CRYO C?

ELITE MPX LASER SYSTEM WITH CRYO C is a medical device that received FDA 510(k) clearance on 2009-05-13. The listed applicant is Cynosure, Inc.. The 510(k) number is K091169.

When did ELITE MPX LASER SYSTEM WITH CRYO C receive FDA 510(k) clearance?

ELITE MPX LASER SYSTEM WITH CRYO C received FDA 510(k) clearance on 2009-05-13, under 510(k) number K091169.

Who is the listed applicant for ELITE MPX LASER SYSTEM WITH CRYO C?

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 ELITE MPX LASER SYSTEM WITH CRYO C?

The FDA product code for ELITE MPX LASER SYSTEM WITH CRYO C 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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