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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Television, Surgical, With Audio
510(k) Number K864381
Device Name LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM
Applicant
Luxtec Corp.
P.O. Box 225, Rte. 20/49
Techno Park Rd.
Sturbridge,  MA  01566
Applicant Contact THOMAS WILK
Correspondent
Luxtec Corp.
P.O. Box 225, Rte. 20/49
Techno Park Rd.
Sturbridge,  MA  01566
Correspondent Contact THOMAS WILK
Regulation Number878.4160
Classification Product Code
FWC  
Date Received11/05/1986
Decision Date 12/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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