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FDA 510(k)

AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE

K-Number: K080006 · 2008-02-28

ApplicantCynosure, Inc.
Decision Date2008-02-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 2008-02-28 under 510(k) number K080006. 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 AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE?

AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE is a medical device that received FDA 510(k) clearance on 2008-02-28. The listed applicant is Cynosure, Inc.. The 510(k) number is K080006.

When did AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE receive FDA 510(k) clearance?

AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE received FDA 510(k) clearance on 2008-02-28, under 510(k) number K080006.

Who is the listed applicant for AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE?

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 AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE?

The FDA product code for AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE 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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