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510(k) K231562

ELEC ENGINE (Model: ISE-170L) by Micro-Nx Co., Ltd. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2025
Date Received
May 31, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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