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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 K033251
Device Name THE FRIENDLYLIGHT ND: YAG LASERS
Applicant
Innotech USA, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, Dc,  DC 
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Innotech USA, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, Dc,  DC 
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/07/2003
Decision Date 03/02/2004
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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