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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 K841781
Device Name MODEL 305AA PORTABLE LASER
Applicant
Laser Spectrum, Inc.
100 S. Wacker Dr.
Chicago,  IL  60606
Applicant Contact ROBERT W BROWNE
Correspondent
Laser Spectrum, Inc.
100 S. Wacker Dr.
Chicago,  IL  60606
Correspondent Contact ROBERT W BROWNE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/30/1984
Decision Date 11/07/1984
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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