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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 K253086
Device Name LED Light Therapy Device (Models: SG-FM, SG-FE)
Applicant
Sunglor Technology Co., Ltd.
Rm. 306, 3nd Floor, Bldg. 4, Fuhai Science Technology
Industrial Park, Fuyong Community, Fuyong St., Baoan Dist
Shenzhen,  CN 518000
Applicant Contact Allen Wu
Correspondent
Sunglor Technology Co., Ltd.
Rm. 306, 3nd Floor, Bldg. 4, Fuhai Science Technology
Industrial Park, Fuyong Community, Fuyong St., Baoan Dist
Shenzhen,  CN 518000
Correspondent Contact Jane Li
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Codes
ILY   OLP  
Date Received09/23/2025
Decision Date 12/19/2025
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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