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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K854027
Device Name LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM
Applicant
Laserscope
3350 Scott Blvd., Bldg.30
Santa Clara,  CA  95051
Applicant Contact ROSS ERICKSON
Correspondent
Laserscope
3350 Scott Blvd., Bldg.30
Santa Clara,  CA  95051
Correspondent Contact ROSS ERICKSON
Regulation Number878.4810
Classification Product Code
LNK  
Date Received10/01/1985
Decision Date 12/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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