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

Numéro K : K160947 · 2016-07-05

Date de décision2016-07-05

Code produitILY

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Usa Laser Biotech, Inc.. The 510(k) number is K160947.

When did 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 receive FDA 510(k) clearance?

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 510(k) number K160947.

Who is the listed applicant 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 510(k) record lists Usa Laser Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Autres dossiers indiquant Usa Laser Biotech, Inc. en tant que demandeur

K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3

Dispositifs connexes (Code : ILY)

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Source officielle

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