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FDA 510(k)

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

K-Number: K160947 · 2016-07-05

ApplicantUsa Laser Biotech, Inc.
Decision Date2016-07-05
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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 is a medical device manufactured by Usa Laser Biotech, Inc.. It received FDA 510(k) clearance on 2016-07-05 under approval number K160947. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2016-07-05. It is manufactured by Usa Laser Biotech, Inc.. The 510(k) number is K160947.

When was 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 approved by the FDA?

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 received FDA 510(k) clearance on 2016-07-05, under approval number K160947.

What company makes 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?

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 is manufactured by Usa Laser Biotech, Inc..

What is the FDA product code for 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?

The FDA product code for 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 is ILY.

Other Devices by Usa Laser Biotech, Inc.

K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3

Related Devices (Code: ILY)

K160849WS(TM) Far-Infrared Therapy Unit, Model KP-B210Ws Far IR Medical Technology Co., Ltd. K152087HeatLux Pro IIHome Skinovations , Ltd. K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc. K153399LightStim Professional LED BedLed Intellectual Properties, LLC K153389Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)In Light Wellness Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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