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510(k) K214100

Luminice by Premier North America, Inc. — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2022
Date Received
December 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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