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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 K994427
Device Name CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL
Applicant
CYNOSURE, INC.
10 ELIZABETH DR.
CHELMSFORD,  MA  01824
Applicant Contact GEORGE CHO
Correspondent
CYNOSURE, INC.
10 ELIZABETH DR.
CHELMSFORD,  MA  01824
Correspondent Contact GEORGE CHO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/30/1999
Decision Date 01/18/2000
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
Predetermined Change
Control Plan Authorized		 No
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