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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 K915651
Device Name OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM
Applicant
Summit Technology, Inc.
21 Hickory Dr.
Waltham,  MA  02154
Applicant Contact MAUREEN O'CONNELL
Correspondent
Summit Technology, Inc.
21 Hickory Dr.
Waltham,  MA  02154
Correspondent Contact MAUREEN O'CONNELL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/18/1991
Decision Date 06/15/1992
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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