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510(k) K211091

Deka Tiac II by El.En Electronic Engineering Spa — Product Code PBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2021
Date Received
April 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Radio Frequency Induced Heat
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

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