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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 K901943
Device Name KTP/532 (TM) SURGICAL LASER
Applicant
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134
Applicant Contact RICHARD P RUDY
Correspondent
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134
Correspondent Contact RICHARD P RUDY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/30/1990
Decision Date 05/29/1990
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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