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FDA 510(k)

Olea Sphere V3.0

K-Number: K152602 · 2016-03-03

ApplicantOlea Medical
Decision Date2016-03-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Olea Sphere V3.0 is a medical device manufactured by Olea Medical. It received FDA 510(k) clearance on 2016-03-03 under approval number K152602. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Olea Sphere V3.0?

Olea Sphere V3.0 is a medical device that received FDA 510(k) clearance on 2016-03-03. It is manufactured by Olea Medical. The 510(k) number is K152602.

When was Olea Sphere V3.0 approved by the FDA?

Olea Sphere V3.0 received FDA 510(k) clearance on 2016-03-03, under approval number K152602.

What company makes Olea Sphere V3.0?

Olea Sphere V3.0 is manufactured by Olea Medical.

What is the FDA product code for Olea Sphere V3.0?

The FDA product code for Olea Sphere V3.0 is LLZ.

Other Devices by Olea Medical

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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.

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