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FDA 510(k)

CANDELA-INOLASE SERENITY PRO PSF SYSTEM

K-Number: K072925 · 2008-01-10

ApplicantInolase, Ltd.
Decision Date2008-01-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA-INOLASE SERENITY PRO PSF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inolase, Ltd.. It received FDA 510(k) clearance on 2008-01-10 under 510(k) number K072925. 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 CANDELA-INOLASE SERENITY PRO PSF SYSTEM?

CANDELA-INOLASE SERENITY PRO PSF SYSTEM is a medical device that received FDA 510(k) clearance on 2008-01-10. The listed applicant is Inolase, Ltd.. The 510(k) number is K072925.

When did CANDELA-INOLASE SERENITY PRO PSF SYSTEM receive FDA 510(k) clearance?

CANDELA-INOLASE SERENITY PRO PSF SYSTEM received FDA 510(k) clearance on 2008-01-10, under 510(k) number K072925.

Who is the listed applicant for CANDELA-INOLASE SERENITY PRO PSF SYSTEM?

The FDA 510(k) record lists Inolase, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANDELA-INOLASE SERENITY PRO PSF SYSTEM?

The FDA product code for CANDELA-INOLASE SERENITY PRO PSF SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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