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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 K042114
Device Name MDL SERIES DIODE LASERS, MODEL MDL-10/15
Applicant
Vision Lasertechnik, GmbH
8135 S. Beaumont Dr.
Sandy,  UT  84093
Applicant Contact ROBERT S HEAD
Correspondent
Vision Lasertechnik, GmbH
8135 S. Beaumont Dr.
Sandy,  UT  84093
Correspondent Contact ROBERT S HEAD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/05/2004
Decision Date 02/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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