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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 K050254
Device Name SPECTRA-SP CO2 LASER SYSTEM
Applicant
Max Engineering , Ltd.
5 Timber Ln.
North Reading,  MA  01864
Applicant Contact MAUREEN O'CONNEL
Correspondent
Max Engineering , Ltd.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact MAUREEN O'CONNEL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/03/2005
Decision Date 04/15/2005
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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