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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 K093545
Device Name PINPOINTE FOOTLASER MODEL 6W, 30W, 100W
Applicant
Incisive, Inc. (Formerly Named Incisive, LLC)
3637 Bernal Ave.
Pleasanton,  CA  94566
Applicant Contact ANNE WORDEN
Correspondent
Incisive, Inc. (Formerly Named Incisive, LLC)
3637 Bernal Ave.
Pleasanton,  CA  94566
Correspondent Contact ANNE WORDEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/17/2009
Decision Date 10/15/2010
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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