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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fat Reducing Low Level Laser
510(k) Number K260129
Device Name Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg.#3 And Bldg.#5, 40th Of Fuxin Streey
Huaide Community Fuyong Town, Baoan District
Shenzhen,  CN 518103
Applicant Contact Alain Dijkstra
Correspondent
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg.#3 And Bldg.#5, 40th Of Fuxin Streey
Huaide Community Fuyong Town, Baoan District
Shenzhen,  CN 518103
Correspondent Contact Alain Dijkstra
Regulation Number878.5400
Classification Product Code
OLI  
Subsequent Product Codes
ILY   OHS  
Date Received01/16/2026
Decision Date 04/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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