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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K170761
Device Name LIGHTSonic BUBM
Applicant
Lightmed USA, Inc.
1130 Calle Cordillera
San Clemente,  CA  92673
Applicant Contact Katrina Hsu
Correspondent
Lightmed USA, Inc.
1130 Calle Cordillera
San Clemente,  CA  92673
Correspondent Contact Angel Hsieh
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/13/2017
Decision Date 04/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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