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FDA 510(k), K150878, ILUMIEN OPTIS
FDA 510(k), K150878, ILUMIEN OPTIS
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510(K) Number: K150878
Device Name: ILUMIEN OPTIS
Manufacturer: ERDIE DE PERALTA
Device Classification Name: System, Imaging, Optical Coherence Tomography (Oct)
Regulation Number: NQQ
Classification Product Code: 04/01/2015
Date Received: 07/15/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ILUMIEN OPTIS
Manufacturer: ERDIE DE PERALTA
Device Classification Name: System, Imaging, Optical Coherence Tomography (Oct)
Regulation Number: NQQ
Classification Product Code: 04/01/2015
Date Received: 07/15/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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