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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 K181523
Device Name Syneron CO2RE System
Applicant
Syneron-Candela Corp
530 Boston Post Road
Wayland,  MA  01778
Applicant Contact Sharon Timberlake
Correspondent
Syneron-Candela Corp
530 Boston Post Road
Wayland,  MA  01778
Correspondent Contact Sharon Timberlake
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/11/2018
Decision Date 07/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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