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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 K990043
Device Name SMOOTHLASE ALEXANDRITE LASER SYSTEM
Applicant
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
Applicant Contact LORNA K LINVILLE
Correspondent
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
Correspondent Contact LORNA K LINVILLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/06/1999
Decision Date 02/11/1999
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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