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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 K875115
Device Name INFRAGUIDE(TM)
Applicant
Cooper Lasersonics, Inc.
3420 Central Expy. .
Santa Clara,  CA  95051
Applicant Contact CHARLES A KANTER
Correspondent
Cooper Lasersonics, Inc.
3420 Central Expy. .
Santa Clara,  CA  95051
Correspondent Contact CHARLES A KANTER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/14/1987
Decision Date 02/26/1988
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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