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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 K911830
Device Name LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER
Applicant
Laserscope
C/O Charles L. Rose & Co., Inc
1963 Rock St., Suite #17
Mountain View,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
Laserscope
C/O Charles L. Rose & Co., Inc
1963 Rock St., Suite #17
Mountain View,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/24/1991
Decision Date 08/14/1991
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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