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FDA 510(k)

OptiLux LED Illuminator

K-Number: K163185 · 2016-11-21

ApplicantIsolux, LLC
Decision Date2016-11-21
Product CodeHBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OptiLux LED Illuminator is the device name listed in this FDA 510(k) record. The listed applicant is Isolux, LLC. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K163185. The device is classified under product code HBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiLux LED Illuminator?

OptiLux LED Illuminator is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Isolux, LLC. The 510(k) number is K163185.

When did OptiLux LED Illuminator receive FDA 510(k) clearance?

OptiLux LED Illuminator received FDA 510(k) clearance on 2016-11-21, under 510(k) number K163185.

Who is the listed applicant for OptiLux LED Illuminator?

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

What is the FDA product code for OptiLux LED Illuminator?

The FDA product code for OptiLux LED Illuminator is HBI.

Related Devices (Code: HBI)

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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