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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 K062312
Device Name AXIOM PULSED LIGHT SYSTEM
Applicant
General Project S.R.L.
56 Westcott Rd.
Stamford,  CT  06902
Applicant Contact CORNELIA DAMSKY
Correspondent
General Project S.R.L.
56 Westcott Rd.
Stamford,  CT  06902
Correspondent Contact CORNELIA DAMSKY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/08/2006
Decision Date 10/16/2006
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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