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FDA 510(k)

Erchonia Emerald

K-Number: K192544 · 2020-01-13

Decision Date2020-01-13
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Erchonia Emerald is a medical device manufactured by Erchonia Corporation. It received FDA 510(k) clearance on 2020-01-13 under approval number K192544. 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 Emerald?

Erchonia Emerald is a medical device that received FDA 510(k) clearance on 2020-01-13. It is manufactured by Erchonia Corporation. The 510(k) number is K192544.

When was Erchonia Emerald approved by the FDA?

Erchonia Emerald received FDA 510(k) clearance on 2020-01-13, under approval number K192544.

What company makes Erchonia Emerald?

Erchonia Emerald is manufactured by Erchonia Corporation.

What is the FDA product code for Erchonia Emerald?

The FDA product code for Erchonia Emerald is OLI.

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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.