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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 K142372
Device Name Pico Way Laser System
Applicant
CANDELA CORPATION
530 BOSTON POST ROAD
WAYLAND,  MA  01778
Applicant Contact Ruthie Amir
Correspondent
HOGAN LOVELLS US LLP
1835 MARKET ST, 29TH FL
PHILADELPHIA,  PA  19103
Correspondent Contact Janice M Hogan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/25/2014
Decision Date 10/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02146807
Reviewed by Third Party No
Combination Product No
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