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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 K260715
Device Name CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)
Applicant
The Beauty Tech Group, Ltd.
Glasshouse, Suite 3f1, Congleton Rd.
Macclesfield,  GB SK10 4ZE
Applicant Contact Harriet Cavanagh
Correspondent
The Beauty Tech Group, Ltd.
Glasshouse, Suite 3f1, Congleton Rd.
Macclesfield,  GB SK10 4ZE
Correspondent Contact Harriet Cavanagh
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received03/05/2026
Decision Date 06/03/2026
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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