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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 K854469
Device Name PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG
Applicant
Minnesota Laser Corp.
6470 Riverview Ter. NE
Minneapolis,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Minnesota Laser Corp.
6470 Riverview Ter. NE
Minneapolis,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/06/1985
Decision Date 02/11/1986
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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