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FDA 510(k), K222166, SOLIX
FDA 510(k), K222166, SOLIX
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510(K) Number: K222166
Device Name: SOLIX
Manufacturer: Optovue, Inc.
Device Classification Name: Tomography, Optical Coherence
Regulation Number: 886.1570
Classification Product Code: OBO
Date Received: 07/21/2022
Decision Date: 11/09/2022
Regulation Medical Specialty: Ophthalmic
Device Name: SOLIX
Manufacturer: Optovue, Inc.
Device Classification Name: Tomography, Optical Coherence
Regulation Number: 886.1570
Classification Product Code: OBO
Date Received: 07/21/2022
Decision Date: 11/09/2022
Regulation Medical Specialty: Ophthalmic
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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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