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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 K922497
Device Name OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM
Applicant
Trimedyne, Inc.
2801 Barranca Rd.
Irvine,  CA  92714
Applicant Contact PAUL S KRAMSKY
Correspondent
Trimedyne, Inc.
2801 Barranca Rd.
Irvine,  CA  92714
Correspondent Contact PAUL S KRAMSKY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/27/1992
Decision Date 03/01/1994
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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