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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 a medical device manufactured by Globalmed Technologies. It received FDA 510(k) clearance on 2021-06-24 under approval 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. It is manufactured by Globalmed Technologies. The 510(k) number is K210948.

When was Omnilux CLEAR approved by the FDA?

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

What company makes Omnilux CLEAR?

Omnilux CLEAR is manufactured by Globalmed Technologies.

What is the FDA product code for Omnilux CLEAR?

The FDA product code for Omnilux CLEAR is OLP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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