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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 K173843
Device Name illumiflow 148 Laser Cap
Applicant
Eglobal, LLC
10115 E Bell Rd.
Suite 107
Scottsdale,  AZ  85260
Applicant Contact Wayne De Stefano
Correspondent
Liza Burns and Associates
6469 G Kawaihau Rd.
Kapaa,  HI  96746
Correspondent Contact Liza Burns
Regulation Number890.5500
Classification Product Code
OAP  
Date Received12/18/2017
Decision Date 01/26/2018
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
Predetermined Change
Control Plan Authorized		 No
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