Erchonia XLR8
K-Number: K211186 · 2021-10-22
ApplicantErchonia Corporation
Decision Date2021-10-22
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Erchonia XLR8 is a medical device manufactured by Erchonia Corporation. It received FDA 510(k) clearance on 2021-10-22 under approval number K211186. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Erchonia XLR8?
Erchonia XLR8 is a medical device that received FDA 510(k) clearance on 2021-10-22. It is manufactured by Erchonia Corporation. The 510(k) number is K211186.
When was Erchonia XLR8 approved by the FDA?
Erchonia XLR8 received FDA 510(k) clearance on 2021-10-22, under approval number K211186.
What company makes Erchonia XLR8?
Erchonia XLR8 is manufactured by Erchonia Corporation.
What is the FDA product code for Erchonia XLR8?
The FDA product code for Erchonia XLR8 is NHN.
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Other Devices by Erchonia Corporation
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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.