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FDA 510(k)

CYNOSURE PHOTOGENICA 532 LASER

K-Number: K974900 · 1998-02-27

ApplicantCynosure, Inc.
Decision Date1998-02-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYNOSURE PHOTOGENICA 532 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 1998-02-27 under 510(k) number K974900. 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 532 LASER?

CYNOSURE PHOTOGENICA 532 LASER is a medical device that received FDA 510(k) clearance on 1998-02-27. The listed applicant is Cynosure, Inc.. The 510(k) number is K974900.

When did CYNOSURE PHOTOGENICA 532 LASER receive FDA 510(k) clearance?

CYNOSURE PHOTOGENICA 532 LASER received FDA 510(k) clearance on 1998-02-27, under 510(k) number K974900.

Who is the listed applicant for CYNOSURE PHOTOGENICA 532 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 CYNOSURE PHOTOGENICA 532 LASER?

The FDA product code for CYNOSURE PHOTOGENICA 532 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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