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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neurosurgical, Argon
510(k) Number K864610
Device Name CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE
Applicant
Inframed, Inc.
100 Crescent Rd.
Needham,  MA  02194
Applicant Contact TIM SHEA
Correspondent
Inframed, Inc.
100 Crescent Rd.
Needham,  MA  02194
Correspondent Contact TIM SHEA
Classification Product Code
LLF  
Date Received11/20/1986
Decision Date 06/18/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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