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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 K193667
Device Name Shapiro MD model laser 272
Applicant
Conversion Labs, PR, LLC
53 Calle Las Palmeras, Suite 802
San Juan,  PR  00901
Applicant Contact Stefan Galluppi
Correspondent
NST Consultants, Inc.
641 Shunpike Road, Suite 311
Chatham,  NJ  07928
Correspondent Contact Raymond R Blanche
Regulation Number890.5500
Classification Product Code
OAP  
Date Received12/31/2019
Decision Date 03/25/2020
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
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