Erchonia Violet ZERONA® Z6 OTC
K-Number: K231474 · 2023-07-21
ApplicantErchonia Corporation
Decision Date2023-07-21
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Erchonia Violet ZERONA® Z6 OTC is a medical device manufactured by Erchonia Corporation. It received FDA 510(k) clearance on 2023-07-21 under approval number K231474. 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 Erchonia Violet ZERONA® Z6 OTC?
Erchonia Violet ZERONA® Z6 OTC is a medical device that received FDA 510(k) clearance on 2023-07-21. It is manufactured by Erchonia Corporation. The 510(k) number is K231474.
When was Erchonia Violet ZERONA® Z6 OTC approved by the FDA?
Erchonia Violet ZERONA® Z6 OTC received FDA 510(k) clearance on 2023-07-21, under approval number K231474.
What company makes Erchonia Violet ZERONA® Z6 OTC?
Erchonia Violet ZERONA® Z6 OTC is manufactured by Erchonia Corporation.
What is the FDA product code for Erchonia Violet ZERONA® Z6 OTC?
The FDA product code for Erchonia Violet ZERONA® Z6 OTC is OLI.
Related Clinical Trials
Other Devices by Erchonia Corporation
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.