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510(k) K120582

HEATLUX by Home Skinovations , Ltd. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2012
Date Received
February 27, 2012
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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