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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 K091285
Device Name AL T LASER, MODEL AVI HPLL-12
Applicant
Avicenna Laser Technology, Inc.
9822 E. Washington St.
Suite 6
Chagrin Falls,  OH  44023
Applicant Contact BRUCE COREN
Correspondent
Avicenna Laser Technology, Inc.
9822 E. Washington St.
Suite 6
Chagrin Falls,  OH  44023
Correspondent Contact BRUCE COREN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/01/2009
Decision Date 07/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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