FDA 510(k)

Skylife

K-Number: K170585 · 2017-10-27

Decision Date2017-10-27

Product CodeLBI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Skylife is the device name listed in this FDA 510(k) record. The listed applicant is Neolight, LLC. It received FDA 510(k) clearance on 2017-10-27 under 510(k) 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. The listed applicant is Neolight, LLC. The 510(k) number is K170585.

When did Skylife receive FDA 510(k) clearance?

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

Who is the listed applicant for Skylife?

The FDA 510(k) record lists Neolight, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Skylife?

The FDA product code for Skylife is LBI.

Other records listing Neolight, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223575Phoenix ICON, Phoenix ICON GO

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.