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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 K150326
Device Name PicoWay Laser System
Candela Corporation
530 boston post road
wayland,  MA  01778
Applicant Contact ruthie amir
Hogan Lovells US LLP
1835 market street, 29th floor
philadelphia,  MA  19103
Correspodent Contact janice m. hogan
Regulation Number878.4810
Classification Product Code
Date Received02/09/2015
Decision Date 04/16/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Clinical Trials NCT02146820
Reviewed by Third Party No
Combination Product No