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510(k) K163079

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System by Healthlight, LLC — Product Code ILY

K163079 is an FDA 510(k) premarket notification submitted by Healthlight, LLC for the device "HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System". The FDA issued a decision of Substantially Equivalent on June 13, 2017. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2017
Date Received
November 3, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

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FDA data resources