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FDA 510(k)

Strialite

K-Number: K151337 · 2016-02-24

ApplicantCentre Light Solutions, LLC
Decision Date2016-02-24
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Strialite is a medical device manufactured by Centre Light Solutions, LLC. It received FDA 510(k) clearance on 2016-02-24 under approval number K151337. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Strialite?

Strialite is a medical device that received FDA 510(k) clearance on 2016-02-24. It is manufactured by Centre Light Solutions, LLC. The 510(k) number is K151337.

When was Strialite approved by the FDA?

Strialite received FDA 510(k) clearance on 2016-02-24, under approval number K151337.

What company makes Strialite?

Strialite is manufactured by Centre Light Solutions, LLC.

What is the FDA product code for Strialite?

The FDA product code for Strialite is OHS.

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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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