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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 K850018
Device Name LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG
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
GEX  
Date Received01/02/1985
Decision Date 06/18/1985
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
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