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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laser, comb, hair
510(k) Number K231153
Device Name Neuhat Hair Growth System; ibeauty.com Laser Cap
Applicant
Nature Incredible Inc
3422 Old Capitol Trail #569
Wilmington,  DE  19808
Applicant Contact John Lee
Correspondent
Nature Incredible Inc
3422 Old Capitol Trail #569
Wilmington,  DE  19808
Correspondent Contact John Lee
Regulation Number890.5500
Classification Product Code
OAP  
Date Received04/24/2023
Decision Date 06/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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