Notal Vision, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Notal Vision, Inc.” (first 2002, latest 2009), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | 2 | 2 |
| HOQ | Grid, Amsler | 1 | 1 |
| SAX | Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device | 1 | 0 |
Review panels
- Ophthalmic (4)
Most recent Notal Vision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091579 | FORESEE HOME | HPT | 2009-12-23 | 204 |
| K050350 | THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) | HPT | 2005-04-29 | 77 |
| K014044 | MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) | HOQ | 2002-03-04 | 87 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230043 | De Novo | Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device | 2024-05-15 |
Recalls
openFDA lists no recalls under a recalling firm named Notal Vision, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Notal Vision, Inc. is the lead sponsor of 13 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05690880: ForeseeHome NRich Registry (Active not recruiting, started 2022-12-15)
- NCT03969303: NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients (Completed, started 2018-10-20)
- NCT03600519: Retinal Imaging Using NOTAL-OCT V2.5 (Completed, started 2018-07-22)
- NCT03270865: Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging (Completed, started 2017-09-30)
- NCT03374020: Retinal Imaging Using NOTAL-OCT (Completed, started 2017-01-17)
Frequently asked questions
How many FDA 510(k) clearances are listed under Notal Vision, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Notal Vision, Inc.” (first 2002, latest 2009), plus 1 De Novo decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Notal Vision, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Notal Vision, Inc. is 87 days.
Which FDA product codes appear under Notal Vision, Inc.?
The most frequent FDA product codes under this applicant name are HPT (Perimeter, Automatic, Ac-Powered, 2); HOQ (Grid, Amsler, 1); SAX (Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device, 1).
Next steps
- See all 3 Notal Vision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HPT, Notal Vision, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.