510(k) K233010

Beagank 4T Plus by Belega, Inc. — Product Code NFO

K233010 is an FDA 510(k) premarket notification submitted by Belega, Inc. for the device "Beagank 4T Plus". The FDA issued a decision of Substantially Equivalent on November 21, 2023. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2023
Date Received
September 22, 2023
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