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FDA 510(k)

CS1000 LIGHT THERAPY DEVICE

K-Number: K110558 · 2012-07-12

ApplicantGenesis Health Light Corporation
Decision Date2012-07-12
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CS1000 LIGHT THERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Health Light Corporation. It received FDA 510(k) clearance on 2012-07-12 under 510(k) number K110558. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS1000 LIGHT THERAPY DEVICE?

CS1000 LIGHT THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 2012-07-12. The listed applicant is Genesis Health Light Corporation. The 510(k) number is K110558.

When did CS1000 LIGHT THERAPY DEVICE receive FDA 510(k) clearance?

CS1000 LIGHT THERAPY DEVICE received FDA 510(k) clearance on 2012-07-12, under 510(k) number K110558.

Who is the listed applicant for CS1000 LIGHT THERAPY DEVICE?

The FDA 510(k) record lists Genesis Health Light Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CS1000 LIGHT THERAPY DEVICE?

The FDA product code for CS1000 LIGHT THERAPY DEVICE is ILY.

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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.

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