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510(k) DEN230043

Notal Vision Home Optical Coherence Tomography (OCT) System by Notal Vision, Inc. — Product Code SAX

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 15, 2024
Date Received
June 7, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
Device Class
Class II
Regulation Number
886.1600
Review Panel
OP
Submission Type

A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments.

Other clearances by Notal Vision, Inc.

  • K091579 — FORESEE HOME (December 23, 2009)
  • K050350 — THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) (April 29, 2005)
  • K014044 — MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (March 4, 2002)