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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 K944630
Device Name MODEL 230-SAS LASER DELIVERY PROBE
Applicant
Mnlase, Inc.
11250 Roger Bacon Dr. #10
Reston,  VA  22090
Applicant Contact BRUCE HEYMANN
Correspondent
Mnlase, Inc.
11250 Roger Bacon Dr. #10
Reston,  VA  22090
Correspondent Contact BRUCE HEYMANN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/20/1994
Decision Date 11/09/1994
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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