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FDA 510(k)

Omnilux CLEAR

K-Number: K210948 · 2021-06-24

ApplicantGlobalmed Technologies
Decision Date2021-06-24
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Omnilux CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Globalmed Technologies. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K210948. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnilux CLEAR?

Omnilux CLEAR is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Globalmed Technologies. The 510(k) number is K210948.

When did Omnilux CLEAR receive FDA 510(k) clearance?

Omnilux CLEAR received FDA 510(k) clearance on 2021-06-24, under 510(k) number K210948.

Who is the listed applicant for Omnilux CLEAR?

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

What is the FDA product code for Omnilux CLEAR?

The FDA product code for Omnilux CLEAR is OLP.

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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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