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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fat reducing low level laser
510(k) Number K143741
Device Name Lipofina Laser System
Applicant
YOLO MEDICAL, INC.
1959 152nd STREET
Suite 245
Carpenteria,  CA BC V4A 9E3
Applicant Contact Robert J Krznaric
Correspondent
ROCKIN' REGULATORY, INC.
21831 Tumbleweed Circle
Lake Forest,  CA  92630
Correspondent Contact Paul Kramsky
Regulation Number878.5400
Classification Product Code
OLI  
Date Received12/31/2014
Decision Date 04/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02187237
Reviewed by Third Party No
Combination Product No
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