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510(k) K192275

invisa-RED ELITE by IR Technology, LLC — Product Code OLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2020
Date Received
August 22, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fat Reducing Low Level Laser
Device Class
Class II
Regulation Number
878.5400
Review Panel
SU
Submission Type

Non-invasive reduction in fat layer for body contouring

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