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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 K994116
Device Name LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
Applicant
Aesculap-Meditec North America
2525 Mc Gaw Ave.
Irvine,  CA  92623
Applicant Contact WILLIAM KELLEY
Correspondent
Aesculap-Meditec North America
2525 Mc Gaw Ave.
Irvine,  CA  92623
Correspondent Contact WILLIAM KELLEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/06/1999
Decision Date 06/01/2000
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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