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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K140719
Device Name PICOSURE WORKSTATION
Applicant
Cynosure, Inc.
5 Calisle Rd.
Westford,  MA  01886
Applicant Contact KEVIN O'CONNELL
Correspondent
Cynosure, Inc.
5 Calisle Rd.
Westford,  MA  01886
Correspondent Contact KEVIN O'CONNELL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/21/2014
Decision Date 09/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02091089
NCT02091102
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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