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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K250618
Device Name Medi Lift Essential Eye Mask
Applicant
Ya-Man, Ltd.
2-4-2 Toyo, Koto-Ku
Tokyo,  JP 1350016
Applicant Contact Jun Takada
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Lina Kontos
Regulation Number882.5890
Classification Product Code
NFO  
Date Received02/28/2025
Decision Date 10/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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