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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K231321
Device Name Nooance Led And Laser Helmet
Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg. #3, And Bldg.#5, 40th 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, 40th Of Fuxin St., Huaide
Community, Fuyong Town, Baoan District
Shenzhen,  CN 518103
Correspondent Contact Alain Dijkstra
Regulation Number890.5500
Classification Product Code
OAP  
Date Received05/08/2023
Decision Date 07/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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