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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 K921842
Device Name CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER
Applicant
Cynosure, Inc.
35 Wiggins Ave.
Bedford,  MA  01730
Applicant Contact GEORGE CHO
Correspondent
Cynosure, Inc.
35 Wiggins Ave.
Bedford,  MA  01730
Correspondent Contact GEORGE CHO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/17/1992
Decision Date 07/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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