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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K011355
Device Name BIOLIGHT PCD
Applicant
Biolight International AB
6740 Riverview Ter.
Minneapolis,,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Biolight International AB
6740 Riverview Ter.
Minneapolis,,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/03/2001
Decision Date 01/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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