510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230043Unknown

Notal Vision Home Optical Coherence Tomography (OCT) System

Notal Vision Ltd., Manassas VA / Direct, Unknown
FDA source (opens on fda.gov)

DEN230043 is the FDA 510(k) clearance record for Notal Vision Home Optical Coherence Tomography (OCT) System, a class II device, cleared for Notal Vision, Inc. on under FDA product code SAX (Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device). FDA's definition for product code SAX reads: "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...". FDA records list 4 510(k) clearances for Notal Vision, Inc., from to . As of , FDA records show no recalls naming DEN230043.

Clearance record

Decision date
Received
(343 days to decision)
Product code
SAX Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
Regulation
21 CFR 886.1600
Device class
Class II
Review panel
Ophthalmic
Applicant
Notal Vision, Inc. 7717 Coppermine Dr., Manassas VA
Third party review
No

Clearances, product code SAX

Trailing 12 months

FDA records hold no clearances under product code SAX in the trailing twelve months.

FDA records show no clearances under product code SAX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SAX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260