FDA 510(k), K123369, ILUMIEN OPTIS

FDA 510(k), K123369, ILUMIEN OPTIS

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510(K) Number: K123369
Device Name: ILUMIEN OPTIS
Manufacturer: LIGHTLAB IMAGING, INC.
Device Classification Name: system, imaging, optical coherence tomography (oct)
Regulation Number: 892.1560
Classification Product Code: NQQ
Date Received: 11/01/2012
Decision Date: 01/30/2013
Regulation Medical Specialty: Radiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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