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510(k) K252786

Led Light Phototherapy Bed (Pro 450/ GY-680A) by Shenzhen Suyzeko Limited. — Product Code OLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2025
Date Received
September 2, 2025
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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