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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 K193008
Device Name Tricoglam Home Use
Advihair S.R.L.
Via Benini 11
Zola Predosa,  IT 40069
Applicant Contact Angleo D’Andrea
Advihair S.R.L.
Via Benini 11
Zola Predosa,  IT 40069
Correspondent Contact Angleo D’Andrea
Regulation Number890.5500
Classification Product Code
Date Received10/28/2019
Decision Date 12/03/2020
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