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FDA 510(k)

EVIS MD PLATINUM RED LIGHT THERAPY

K-Number: K082247 · 2008-10-08

ApplicantAgeless Beauty Corporation
Decision Date2008-10-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EVIS MD PLATINUM RED LIGHT THERAPY 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 2008-10-08 under 510(k) number K082247. 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 PLATINUM RED LIGHT THERAPY?

EVIS MD PLATINUM RED LIGHT THERAPY is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is Ageless Beauty Corporation. The 510(k) number is K082247.

When did EVIS MD PLATINUM RED LIGHT THERAPY receive FDA 510(k) clearance?

EVIS MD PLATINUM RED LIGHT THERAPY received FDA 510(k) clearance on 2008-10-08, under 510(k) number K082247.

Who is the listed applicant for EVIS MD PLATINUM RED LIGHT THERAPY?

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 PLATINUM RED LIGHT THERAPY?

The FDA product code for EVIS MD PLATINUM RED LIGHT THERAPY is GEX. This falls under the Gastroenterology category.

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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.

K082232EVIS MD PLANTIUM BLUE

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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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