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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 K150587
Device Name Cortex Laser System
Applicant
Cynosure, Inc. Dba Ellman
400 Karin Lane
Hicksville,  NY  11801
Applicant Contact Allison Sathe
Correspondent
Cynosure, Inc. Dba Ellman
400 Karin Lane
Hicksville,  NY  11801
Correspondent Contact Allison Sathe
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/09/2015
Decision Date 07/21/2015
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
Predetermined Change
Control Plan Authorized		 No
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