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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 K945888
Device Name MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM
Applicant
Luxar Corp.
19204 N. Creek Paryway
Suite 100
Bothell,  WA  98011
Applicant Contact PHILLIP BURWELL
Correspondent
Luxar Corp.
19204 N. Creek Paryway
Suite 100
Bothell,  WA  98011
Correspondent Contact PHILLIP BURWELL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/01/1994
Decision Date 01/27/1995
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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