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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 K173729
Device Name REVIAN RED
Applicant
PhotonMD, Inc
627 Davis Drive, Suite 400
morrisville,  NC  27560
Applicant Contact william a knape
Correspondent
PhotonMD, Inc
627 Davis Drive, Suite 400
morrisville,  NC  27560
Correspondent Contact william a knape
Regulation Number890.5500
Classification Product Code
OAP  
Date Received12/06/2017
Decision Date 02/28/2018
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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