FDA 510(k)

invisa-RED ELITE

K-Number: K192275 · 2020-08-19

Decision Date2020-08-19

Product CodeOLI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

invisa-RED ELITE is the device name listed in this FDA 510(k) record. The listed applicant is IR Technology, LLC. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K192275. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the invisa-RED ELITE?

invisa-RED ELITE is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is IR Technology, LLC. The 510(k) number is K192275.

When did invisa-RED ELITE receive FDA 510(k) clearance?

invisa-RED ELITE received FDA 510(k) clearance on 2020-08-19, under 510(k) number K192275.

Who is the listed applicant for invisa-RED ELITE?

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

What is the FDA product code for invisa-RED ELITE?

The FDA product code for invisa-RED ELITE is OLI.

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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.