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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 K090762
Device Name LEDA
Applicant
Quantel Derma GmbH
Am Wolfsmantel 46
Erlangen,  DE D-91058
Applicant Contact DIETMAR FISCHER
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONF  
Date Received03/23/2009
Decision Date 08/28/2009
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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