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FDA 510(k)

CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER

K-Number: K992757 · 2000-06-29

ApplicantCynosure, Inc.
Decision Date2000-06-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYNOSURE APOGEE-TKS DERMATOLOGICAL 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 2000-06-29 under 510(k) number K992757. 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 APOGEE-TKS DERMATOLOGICAL LASER?

CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER is a medical device that received FDA 510(k) clearance on 2000-06-29. The listed applicant is Cynosure, Inc.. The 510(k) number is K992757.

When did CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER receive FDA 510(k) clearance?

CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER received FDA 510(k) clearance on 2000-06-29, under 510(k) number K992757.

Who is the listed applicant for CYNOSURE APOGEE-TKS DERMATOLOGICAL 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 APOGEE-TKS DERMATOLOGICAL LASER?

The FDA product code for CYNOSURE APOGEE-TKS DERMATOLOGICAL 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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