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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 K915497
Device Name CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM
Applicant
Continuum Biomedical, Inc.
1963 Rock St.
Suite #17
Mountain View,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
Continuum Biomedical, Inc.
1963 Rock St.
Suite #17
Mountain View,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/09/1991
Decision Date 03/06/1992
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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