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FDA 510(k)

ILUMIEN OPTIS

K-Number: K123369 · 2013-01-30

ApplicantLightlab Imaging, Inc.
Decision Date2013-01-30
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ILUMIEN OPTIS is the device name listed in this FDA 510(k) record. The listed applicant is Lightlab Imaging, Inc.. It received FDA 510(k) clearance on 2013-01-30 under 510(k) number K123369. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILUMIEN OPTIS?

ILUMIEN OPTIS is a medical device that received FDA 510(k) clearance on 2013-01-30. The listed applicant is Lightlab Imaging, Inc.. The 510(k) number is K123369.

When did ILUMIEN OPTIS receive FDA 510(k) clearance?

ILUMIEN OPTIS received FDA 510(k) clearance on 2013-01-30, under 510(k) number K123369.

Who is the listed applicant for ILUMIEN OPTIS?

The FDA 510(k) record lists Lightlab Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ILUMIEN OPTIS?

The FDA product code for ILUMIEN OPTIS is NQQ.

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Related Devices (Code: NQQ)

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Official Source

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

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