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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 K901127
Device Name LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY
Applicant
Lasercomp
16630 Aston St.
Irvine,  CA  92714
Applicant Contact MICHAEL MORETTI
Correspondent
Lasercomp
16630 Aston St.
Irvine,  CA  92714
Correspondent Contact MICHAEL MORETTI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/12/1990
Decision Date 09/10/1990
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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