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FDA 510(k)

OMNILUX REVIVE AND OMNILUX PLUS

K-Number: K050216 · 2005-08-09

ApplicantPhoto Therapeutics Limited
Decision Date2005-08-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNILUX REVIVE AND OMNILUX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Photo Therapeutics Limited. It received FDA 510(k) clearance on 2005-08-09 under 510(k) number K050216. 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 OMNILUX REVIVE AND OMNILUX PLUS?

OMNILUX REVIVE AND OMNILUX PLUS is a medical device that received FDA 510(k) clearance on 2005-08-09. The listed applicant is Photo Therapeutics Limited. The 510(k) number is K050216.

When did OMNILUX REVIVE AND OMNILUX PLUS receive FDA 510(k) clearance?

OMNILUX REVIVE AND OMNILUX PLUS received FDA 510(k) clearance on 2005-08-09, under 510(k) number K050216.

Who is the listed applicant for OMNILUX REVIVE AND OMNILUX PLUS?

The FDA 510(k) record lists Photo Therapeutics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNILUX REVIVE AND OMNILUX PLUS?

The FDA product code for OMNILUX REVIVE AND OMNILUX PLUS is GEX. This falls under the Gastroenterology category.

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Other records listing Photo Therapeutics Limited 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.

K043329OMNILUX REVIVE AND BLUEK043317OMNILUX PLUSK030426OMNILUX REDK030883OMNILUX 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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