Home / 510(k) Clearances / K160947

510(k) K160947

LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System by Usa Laser Biotech, Inc. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2016
Date Received
April 5, 2016
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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  • K042256 — IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 10 (November 17, 2004)

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