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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 K040659
Device Name MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM
Applicant
Mccue Plc
Solent Industrial Estate
Hedge End.
Southampton, Hampshire,  GB SO30-2FY
Applicant Contact STEVEN PEACH
Correspondent
Bsi Healthcare
Kitemark Ct., Davy Ave.
Knowlhill
Milton Keynes,  GB MK5 8PP
Correspondent Contact JOHN W HOWLETT
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/12/2004
Decision Date 06/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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