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FDA 510(k)

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3

K-Number: K161198 · 2016-07-26

ApplicantUsa Laser Biotech, Inc.
Decision Date2016-07-26
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 is a medical device manufactured by Usa Laser Biotech, Inc.. It received FDA 510(k) clearance on 2016-07-26 under approval number K161198. 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 Ultra 1, Lumix Ultra 2, Lumix Ultra 3?

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 is a medical device that received FDA 510(k) clearance on 2016-07-26. It is manufactured by Usa Laser Biotech, Inc.. The 510(k) number is K161198.

When was Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 approved by the FDA?

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 received FDA 510(k) clearance on 2016-07-26, under approval number K161198.

What company makes Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3?

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 is manufactured by Usa Laser Biotech, Inc..

What is the FDA product code for Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3?

The FDA product code for Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 is ILY.

Other Devices by Usa Laser Biotech, Inc.

K160947LUMIX 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

Related Devices (Code: ILY)

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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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