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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 K892912
Device Name MODEL JM-1 CO2 LASER
Applicant
L.A.S.E.R., Inc.
266 E. 3200 N.
Provo,  UT  84604
Applicant Contact J STODDARD
Correspondent
L.A.S.E.R., Inc.
266 E. 3200 N.
Provo,  UT  84604
Correspondent Contact J STODDARD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/20/1989
Decision Date 03/06/1990
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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