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FDA 510(k)

AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM

K-Number: K050382 · 2005-09-14

ApplicantCynosure, Inc.
Decision Date2005-09-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AFFINITY QS Q-SWITCHED ND:YAG LASER 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 2005-09-14 under 510(k) number K050382. 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 AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM?

AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-14. The listed applicant is Cynosure, Inc.. The 510(k) number is K050382.

When did AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM receive FDA 510(k) clearance?

AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM received FDA 510(k) clearance on 2005-09-14, under 510(k) number K050382.

Who is the listed applicant for AFFINITY QS Q-SWITCHED ND:YAG LASER 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 AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM?

The FDA product code for AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

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