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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 K053201
Device Name CURAE'LASE CL1000 IR LASER SYSTEM
Applicant
Curae'Lase, Inc.
12101 Cullen Blvd.
Suite A
Houston,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
Curae'Lase, Inc.
12101 Cullen Blvd.
Suite A
Houston,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received11/16/2005
Decision Date 12/09/2005
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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