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FDA 510(k)

CYNOSURE SMART FILE ND:YAG LASERS

K-Number: K031125 · 2003-10-09

ApplicantCynosure, Inc.
Decision Date2003-10-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYNOSURE SMART FILE ND:YAG LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 2003-10-09 under 510(k) number K031125. 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 SMART FILE ND:YAG LASERS?

CYNOSURE SMART FILE ND:YAG LASERS is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is Cynosure, Inc.. The 510(k) number is K031125.

When did CYNOSURE SMART FILE ND:YAG LASERS receive FDA 510(k) clearance?

CYNOSURE SMART FILE ND:YAG LASERS received FDA 510(k) clearance on 2003-10-09, under 510(k) number K031125.

Who is the listed applicant for CYNOSURE SMART FILE ND:YAG LASERS?

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 SMART FILE ND:YAG LASERS?

The FDA product code for CYNOSURE SMART FILE ND:YAG LASERS 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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