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510(k) K042256

IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE by Usa Laser Biotech, Inc. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2004
Date Received
August 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

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