Zerona Z6 OTC
K-Number: K162578 · 2016-12-16
ApplicantErchonia Corporation
Decision Date2016-12-16
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Zerona Z6 OTC is a medical device manufactured by Erchonia Corporation. It received FDA 510(k) clearance on 2016-12-16 under approval number K162578. 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 Zerona Z6 OTC?
Zerona Z6 OTC is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Erchonia Corporation. The 510(k) number is K162578.
When was Zerona Z6 OTC approved by the FDA?
Zerona Z6 OTC received FDA 510(k) clearance on 2016-12-16, under approval number K162578.
What company makes Zerona Z6 OTC?
Zerona Z6 OTC is manufactured by Erchonia Corporation.
What is the FDA product code for Zerona Z6 OTC?
The FDA product code for 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.