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FDA 510(k)

CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM

K-Number: K974674 · 1998-04-29

ApplicantCynosure, Inc.
Decision Date1998-04-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 1998-04-29 under 510(k) number K974674. 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 PHOTOLIGHT FLASHLAMP SYSTEM?

CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-29. The listed applicant is Cynosure, Inc.. The 510(k) number is K974674.

When did CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM receive FDA 510(k) clearance?

CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM received FDA 510(k) clearance on 1998-04-29, under 510(k) number K974674.

Who is the listed applicant for CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM?

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 PHOTOLIGHT FLASHLAMP SYSTEM?

The FDA product code for CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM 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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