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FDA 510(k)

Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)

K-Number: K153389 · 2016-03-30

ApplicantIn Light Wellness Systems, Inc.
Decision Date2016-03-30
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) is the device name listed in this FDA 510(k) record. The listed applicant is In Light Wellness Systems, Inc.. It received FDA 510(k) clearance on 2016-03-30 under 510(k) number K153389. 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 Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)?

Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) is a medical device that received FDA 510(k) clearance on 2016-03-30. The listed applicant is In Light Wellness Systems, Inc.. The 510(k) number is K153389.

When did Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) receive FDA 510(k) clearance?

Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) received FDA 510(k) clearance on 2016-03-30, under 510(k) number K153389.

Who is the listed applicant for Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)?

The FDA 510(k) record lists In Light Wellness Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)?

The FDA product code for Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) 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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