invisa-RED ELITE
K-Number: K192275 · 2020-08-19
ApplicantIR Technology, LLC
Decision Date2020-08-19
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
invisa-RED ELITE is a medical device manufactured by IR Technology, LLC. It received FDA 510(k) clearance on 2020-08-19 under approval 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. It is manufactured by IR Technology, LLC. The 510(k) number is K192275.
When was invisa-RED ELITE approved by the FDA?
invisa-RED ELITE received FDA 510(k) clearance on 2020-08-19, under approval number K192275.
What company makes invisa-RED ELITE?
invisa-RED ELITE is manufactured by IR Technology, LLC.
What is the FDA product code for invisa-RED ELITE?
The FDA product code for invisa-RED ELITE is OLI.
Related Devices (Code: OLI)
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.