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FDA 510(k)

SMART 2940 D ER: YAG LASER

K-Number: K031317 · 2003-05-22

ApplicantCynosure, Inc.
Decision Date2003-05-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMART 2940 D ER: YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K031317. 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 SMART 2940 D ER: YAG LASER?

SMART 2940 D ER: YAG LASER is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is Cynosure, Inc.. The 510(k) number is K031317.

When did SMART 2940 D ER: YAG LASER receive FDA 510(k) clearance?

SMART 2940 D ER: YAG LASER received FDA 510(k) clearance on 2003-05-22, under 510(k) number K031317.

Who is the listed applicant for SMART 2940 D ER: YAG LASER?

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 SMART 2940 D ER: YAG LASER?

The FDA product code for SMART 2940 D ER: YAG LASER 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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