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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 K203826
Device Name LaserCap Family of Lasers 300, 224, 120 & 80
Applicant
Transdermal Cap, Inc.
26 Alpha Park
Highland Heights,  OH  44143
Applicant Contact Michael Rabin
Correspondent
NST Consultants, Inc.
5 Cold Hill Road South
Mendham,  NJ  07945
Correspondent Contact Raymond R Blanche
Regulation Number890.5500
Classification Product Code
OAP  
Date Received12/29/2020
Decision Date 03/29/2021
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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