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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 K934865
Device Name OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM
Applicant
Trimedyne, Inc.
2801 Barranca Rd.
Irvine,  CA  92714
Applicant Contact LOUIE GORYOKA
Correspondent
Trimedyne, Inc.
2801 Barranca Rd.
Irvine,  CA  92714
Correspondent Contact LOUIE GORYOKA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/12/1993
Decision Date 05/12/1994
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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