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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 K102359
Device Name PICASSO/ PICASSO LITE/ PICASSO PERIO
Applicant
Amd Lasers, LLC
7405 Westfield Blvd.
Indianapolis,  IN  46240
Applicant Contact AMY SZENTES
Correspondent
Amd Lasers, LLC
7405 Westfield Blvd.
Indianapolis,  IN  46240
Correspondent Contact AMY SZENTES
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/19/2010
Decision Date 09/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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