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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K251781
Device Name KALA MINI 2.0 (KALA-04)
Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg. #3 And Bldg. #5, #40 Of Fuxin St., 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, #40 Of Fuxin St., Huaide
Community, Fuyong Town, Baoan District
Shenzhen,  CN 518103
Correspondent Contact Alain Dijkstra
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
ILY  
Date Received06/11/2025
Decision Date 09/04/2025
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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