510(k) K153399

LightStim Professional LED Bed by Led Intellectual Properties, LLC — Product Code ILY

K153399 is an FDA 510(k) premarket notification submitted by Led Intellectual Properties, LLC for the device "LightStim Professional LED Bed". The FDA issued a decision of Substantially Equivalent on July 5, 2016. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Led Intellectual Properties, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2016
Date Received
November 24, 2015
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