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510(k) K161198

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 by Usa Laser Biotech, Inc. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2016
Date Received
April 28, 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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