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510(k) K260129

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) by Shenzhen Kaiyan Medical Equipment Co., Ltd. — Product Code OLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2026
Date Received
January 16, 2026
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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