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FDA 510(k)

Skylife

K-Number: K170585 · 2017-10-27

ApplicantNeolight, LLC
Decision Date2017-10-27
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Skylife is a medical device manufactured by Neolight, LLC. It received FDA 510(k) clearance on 2017-10-27 under approval number K170585. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Skylife?

Skylife is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Neolight, LLC. The 510(k) number is K170585.

When was Skylife approved by the FDA?

Skylife received FDA 510(k) clearance on 2017-10-27, under approval number K170585.

What company makes Skylife?

Skylife is manufactured by Neolight, LLC.

What is the FDA product code for Skylife?

The FDA product code for Skylife is LBI.

Other Devices by Neolight, LLC

K223575Phoenix ICON, Phoenix ICON GO

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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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