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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 K261482
Device Name LightStim for Wrinkles (1984); LightStim for Acne (2038)
Applicant
Led Intellectual Properties, LLC
16552 Von Karman Ave.
Irvine,  CA  92606
Applicant Contact Brian Purcell
Correspondent
Led Intellectual Properties, LLC
16552 Von Karman Ave.
Irvine,  CA  92606
Correspondent Contact Brian Purcell
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received05/05/2026
Decision Date 07/31/2026
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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