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FDA 510(k)

EVIS MD PLANTIUM BLUE

K-Number: K082232 · 2008-10-15

ApplicantAgeless Beauty Corporation
Decision Date2008-10-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EVIS MD PLANTIUM BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Ageless Beauty Corporation. It received FDA 510(k) clearance on 2008-10-15 under 510(k) number K082232. 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 EVIS MD PLANTIUM BLUE?

EVIS MD PLANTIUM BLUE is a medical device that received FDA 510(k) clearance on 2008-10-15. The listed applicant is Ageless Beauty Corporation. The 510(k) number is K082232.

When did EVIS MD PLANTIUM BLUE receive FDA 510(k) clearance?

EVIS MD PLANTIUM BLUE received FDA 510(k) clearance on 2008-10-15, under 510(k) number K082232.

Who is the listed applicant for EVIS MD PLANTIUM BLUE?

The FDA 510(k) record lists Ageless Beauty Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVIS MD PLANTIUM BLUE?

The FDA product code for EVIS MD PLANTIUM BLUE 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 Ageless Beauty Corporation 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.

K082247EVIS MD PLATINUM RED LIGHT THERAPY

Related Devices (Code: GEX)

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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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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