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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 K901638
Device Name MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33
Applicant
Lasermatic, Inc.
Medical Device Consultants Inc
45 W. Streert, Suite 2
Attleboro,  MA  02703
Applicant Contact TOBY FULLER
Correspondent
Lasermatic, Inc.
Medical Device Consultants Inc
45 W. Streert, Suite 2
Attleboro,  MA  02703
Correspondent Contact TOBY FULLER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/09/1990
Decision Date 06/27/1990
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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