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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 K933245
Device Name ULTRALINE II STERILE DISPOSABLE FIBER
Applicant
Heraeus Lasersonics, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035
Applicant Contact ROBERT MILDER
Correspondent
Heraeus Lasersonics, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035
Correspondent Contact ROBERT MILDER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/02/1993
Decision Date 04/21/1994
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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