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FDA 510(k)

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System

K-Number: K163079 · 2017-06-13

ApplicantHealthlight, LLC
Decision Date2017-06-13
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Healthlight, LLC. It received FDA 510(k) clearance on 2017-06-13 under 510(k) number K163079. 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 HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System?

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System is a medical device that received FDA 510(k) clearance on 2017-06-13. The listed applicant is Healthlight, LLC. The 510(k) number is K163079.

When did HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System receive FDA 510(k) clearance?

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System received FDA 510(k) clearance on 2017-06-13, under 510(k) number K163079.

Who is the listed applicant for HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System?

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

What is the FDA product code for HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System?

The FDA product code for HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System is ILY.

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Official Source

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