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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 K160607
Device Name PicoWay Laser System
Applicant
SYNERON CANDELA CORPORATION
530 BOSTON POST ROAD
Wayland,  MA  01778
Applicant Contact Ruthie Amir
Correspondent
HOGAN LOVELLS US, LLP
1835 MARKET STREET, 29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/02/2016
Decision Date 07/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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