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FDA 510(k)

PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT

K-Number: K051442 · 2006-05-24

ApplicantCynosure, Inc.
Decision Date2006-05-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 2006-05-24 under 510(k) number K051442. 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 PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT?

PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT is a medical device that received FDA 510(k) clearance on 2006-05-24. The listed applicant is Cynosure, Inc.. The 510(k) number is K051442.

When did PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT receive FDA 510(k) clearance?

PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT received FDA 510(k) clearance on 2006-05-24, under 510(k) number K051442.

Who is the listed applicant for PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT?

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 PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT?

The FDA product code for PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT 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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