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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 K242441
Device Name Revian Lyte (10011)
Applicant
Revian, Inc.
615 Davis Drive
Suite 800
Morrisville,  NC  27560
Applicant Contact Tammy Carrea
Correspondent
Revian, Inc.
615 Davis Drive
Suite 800
Morrisville,  NC  27560
Correspondent Contact Tammy Carrea
Regulation Number890.5500
Classification Product Code
OAP  
Date Received08/16/2024
Decision Date 09/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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