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FDA 510(k)

CYNOSURE DIODERM

K-Number: K992765 · 1999-09-08

ApplicantCynosure, Inc.
Decision Date1999-09-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYNOSURE DIODERM is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 1999-09-08 under 510(k) number K992765. 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 DIODERM?

CYNOSURE DIODERM is a medical device that received FDA 510(k) clearance on 1999-09-08. The listed applicant is Cynosure, Inc.. The 510(k) number is K992765.

When did CYNOSURE DIODERM receive FDA 510(k) clearance?

CYNOSURE DIODERM received FDA 510(k) clearance on 1999-09-08, under 510(k) number K992765.

Who is the listed applicant for CYNOSURE DIODERM?

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 DIODERM?

The FDA product code for CYNOSURE DIODERM 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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