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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 K013021
Device Name LIGHTLANCE LASER SKIN PERFORATOR
Applicant
Innotech USA, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, Dc,  DC 
Applicant Contact HOWARD HOLSTEIN
Correspondent
Innotech USA, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, Dc,  DC 
Correspondent Contact HOWARD HOLSTEIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/07/2001
Decision Date 05/30/2002
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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