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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 K250413
Device Name Aglaia LED Beauty Device (BP-D2309)
Applicant
Shenzhen Perfect Idea Technology Limited
4f, Bldg. 1, Fuhua Industrial Park, Tangwei,
Fuyong, Bao’An
Shenzhen,  CN 518103
Applicant Contact Zhuo Zhan
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 805, #19 Dongbao Rd., Songjiang Area
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received02/13/2025
Decision Date 03/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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