Erchonia Zerona® VZ8
K-Number: K243811 · 2025-01-10
ApplicantErchonia Corporation
Decision Date2025-01-10
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Erchonia Zerona® VZ8 is a medical device manufactured by Erchonia Corporation. It received FDA 510(k) clearance on 2025-01-10 under approval number K243811. 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 Zerona® VZ8?
Erchonia Zerona® VZ8 is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Erchonia Corporation. The 510(k) number is K243811.
When was Erchonia Zerona® VZ8 approved by the FDA?
Erchonia Zerona® VZ8 received FDA 510(k) clearance on 2025-01-10, under approval number K243811.
What company makes Erchonia Zerona® VZ8?
Erchonia Zerona® VZ8 is manufactured by Erchonia Corporation.
What is the FDA product code for Erchonia Zerona® VZ8?
The FDA product code for Erchonia Zerona® VZ8 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.