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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 K862514
Device Name OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO
Applicant
LASERSCOPE
3350 SCOTT BLVD., BLDG.30
SANTA CLARA,  CA  95051
Applicant Contact RICHARD P RUDY
Correspondent
LASERSCOPE
3350 SCOTT BLVD., BLDG.30
SANTA CLARA,  CA  95051
Correspondent Contact RICHARD P RUDY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/01/1986
Decision Date 02/04/1987
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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