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510(k) K150175

HeatLux Pro I by Home Skinovations , Ltd. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2015
Date Received
January 26, 2015
Clearance Type
Special
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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