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 a medical device manufactured by Isolux, LLC. It received FDA 510(k) clearance on 2016-11-21 under approval 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. It is manufactured by Isolux, LLC. The 510(k) number is K163185.
When was OptiLux LED Illuminator approved by the FDA?
OptiLux LED Illuminator received FDA 510(k) clearance on 2016-11-21, under approval number K163185.
What company makes OptiLux LED Illuminator?
OptiLux LED Illuminator is manufactured by Isolux, LLC.
What is the FDA product code for OptiLux LED Illuminator?
The FDA product code for OptiLux LED Illuminator is HBI.
Related Devices (Code: HBI)
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.