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FDA 510(k)

CYNOSURE PHOTOGENICA DL

K-Number: K010005 · 2001-04-02

ApplicantCynosure, Inc.
Decision Date2001-04-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYNOSURE PHOTOGENICA DL is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 2001-04-02 under 510(k) number K010005. 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 PHOTOGENICA DL?

CYNOSURE PHOTOGENICA DL is a medical device that received FDA 510(k) clearance on 2001-04-02. The listed applicant is Cynosure, Inc.. The 510(k) number is K010005.

When did CYNOSURE PHOTOGENICA DL receive FDA 510(k) clearance?

CYNOSURE PHOTOGENICA DL received FDA 510(k) clearance on 2001-04-02, under 510(k) number K010005.

Who is the listed applicant for CYNOSURE PHOTOGENICA DL?

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 PHOTOGENICA DL?

The FDA product code for CYNOSURE PHOTOGENICA DL 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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