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FDA 510(k)

SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM

K-Number: K062589 · 2006-11-30

ApplicantInolase 2002, Ltd.
Decision Date2006-11-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inolase 2002, Ltd.. It received FDA 510(k) clearance on 2006-11-30 under 510(k) number K062589. 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 SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM?

SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM is a medical device that received FDA 510(k) clearance on 2006-11-30. The listed applicant is Inolase 2002, Ltd.. The 510(k) number is K062589.

When did SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM receive FDA 510(k) clearance?

SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM received FDA 510(k) clearance on 2006-11-30, under 510(k) number K062589.

Who is the listed applicant for SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM?

The FDA 510(k) record lists Inolase 2002, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM?

The FDA product code for SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Inolase 2002, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071943SERENITY PRO PSF SYSTEM

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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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