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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument
510(k) Number K171055
Device Name Philips BlueControl
Applicant
Philips Electronics Nederland B.V.
High Tech Campus 5
Eindhoven,  NL 5656 AE
Applicant Contact Gaozhen Hang
Correspondent
Philips Electronics Nederland B.V.
High Tech Campus 5
Eindhoven,  NL 5656 AE
Correspondent Contact Gaozhen Hang
Regulation Number878.4810
Classification Product Code
ONE  
Date Received04/10/2017
Decision Date 07/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02004847
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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