Heru, Inc.

Heru, Inc., a Miami company, appears to be building a wearable eye exam: it has registered nine separate eye tests with the FDA, each as its own Class I device. The QTO manufacturer list shows only one of those tests, a digital acuity check, among 27 makers. Class I registration is not FDA clearance.

The nine devices

Dates are the listing dates. The name is Heru’s, when the listing has one.

1. 2020-11-24 — Heru Visual Field (HPT). How far side vision extends.
2. 2022-08-15 — Heru Color Vision Test, Ishihara and D-15 (HIT). Whether someone can tell colors apart.
3. 2022-08-15 — Heru Contrast Sensitivity (HOX). The trade name says contrast. The FDA device name is Chart, Visual Acuity. Those are not the same description.
4. 2022-08-15 — Heru Dark Adaptation (OUM). How the eye adapts to darkness, and the dimmest light it can still see.
5. 2023-03-28 — no trade name (QTO). How sharp vision is. This is the digital visual acuity test on the QTO list.
6. 2023-03-28 — no trade name (HLG). The width of the pupil.
7. 2023-03-30 — Heru Eye Motility (HJS). Whether the eye muscles are balanced.
8. 2023-03-30 — Heru Cover Test (HJQ). The angle of a turned eye, and whether the two eyes work together.
9. 2025-07-01 — Heru Refract (HKO). The focusing power of the eye.

How this was checked

On 2026-10-02 UTC, the openFDA registration listing for FEI 3017657497 returned nine records. All of them are named HERU, INC., at 201 S Biscayne Blvd Suite 2866, Miami, FL 33131. The owner is Heru, Inc., number 10079219. The official correspondent is Mohamed Abou Shousha. Every record lists the same three establishment types: Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198. That is the live wording of the three roles on the QTO row. None of the nine records has a 510(k) number or a PMA number.

The committed 16 September 2026 QTO snapshot lists HERU, INC. in Miami, FL, as one of the 27 makers. Its sentence for Heru is the mixed registration: develops specifications and does not manufacture at this facility; maintains the complaint file; manufactures this device. The manufacture rule counts a Manufacturer or Contract manufacturer tag, including mixed registrations. That row does not say the same establishment has eight other Class I ophthalmic listings, that the earliest in this set is a visual-field perimeter from 2020-11-24, that “Heru Contrast Sensitivity” is filed under a visual-acuity-chart code, or that a journal paper describes the visual-field test as software on a headset.

Public device type, class, and regulation, from the openFDA classification record and the 2024 Code of Federal Regulations:

• HPT. Perimeter, Automatic, Ac-Powered. Class 1, ophthalmic, regulation 886.1605. 21 CFR 886.1605 (2024): “A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient.”
• HIT. Tester, Color Vision. Class 1, regulation 886.1170. The listing has two trade names, Heru Color Vision Test, Ishihara, and Heru Color Vision Test, D-15. 21 CFR 886.1170 (2024) says a color vision tester consists of various colored materials, such as colored yarns or color vision plates, intended to evaluate color vision.
• HOX. Chart, Visual Acuity. Class 1, regulation 886.1150. 21 CFR 886.1150 (2024) identifies a visual acuity chart, such as a Snellen chart, intended to test visual acuity.
• OUM. Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation. Class 1, regulation 886.1050. The classification definition is: “Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light.” 21 CFR 886.1050 (2024) says an adaptometer is an AC-powered device that provides a stimulating light source of various controlled intensities, intended to measure the time required for retinal adaptation and the minimum light threshold.
• QTO. Digital Visual Acuity Test. Class 1, regulation 886.1150, the same regulation number as HOX and a different product code. The classification definition is: “A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients.”
• HLG. Pupillometer, Ac-Powered. Class 1, regulation 886.1700. 21 CFR 886.1700 (2024): “A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.”
• HJS. Test, Spectacle Dissociation, Ac-Powered (Lancaster). Class 1, regulation 886.1910. 21 CFR 886.1910 (2024) says a spectacle dissociation test system, such as a Lancaster test, uses a light source and filters, usually red or green, and is intended to subjectively measure imbalance of ocular muscles.
• HJQ. Stereoscope, Ac-Powered. Class 1, regulation 886.1870. 21 CFR 886.1870 (2024) says a stereoscope combines the images of two similar objects to produce a three-dimensional appearance, and is intended to measure the angle of strabismus, evaluate binocular vision, and guide corrective exercises of eye muscles.
• HKO. Refractometer, Ophthalmic. Class 1, regulation 886.1760. 21 CFR 886.1760 (2024) says an ophthalmic refractometer is an automatic AC-powered device with a fixation system, a measurement and recording system, and an alignment system, intended to measure the refractive power of the eye by measuring light reflexes from the retina.

A 2023 paper describes the visual-field test as headset software. Quoted from the paper: “we introduce the Heru re:Vive, a US Food and Drug Administration-registered software platform that uses a commercially available VR HMD with AR capability for visual field testing.” Source: Journal of Glaucoma, 2023;32(8):647–657, doi:10.1097/IJG.0000000000002238, PMC10414153. Mohamed Abou Shousha is listed there with affiliations at Bascom Palmer Eye Institute and at Heru, Inc., the same name as the FDA official correspondent. The paper describes that visual-field test. It does not describe the other eight product codes.

The Heru product page describes visual acuity, Ishihara color vision, cover testing, extraocular motility, and quantitative pupillometry as modalities on a VR headset it calls Heru Prime. Time claims, percents, and a testimonial on that page are not used here. The saved text of that page does not contain the words contrast, dark adaptation, or refract. Those trade names are on the FDA listings.

Two patents sit next to that picture and have different assignees. US 12,357,172, “Visual field map expansion”, inventor Mohamed Abou Shousha, assignee Heru Inc., application 17/538,862 filed 2021-11-30, issued 2025-07-15. US 11,659,987, “Vision testing via prediction-based setting of initial stimuli characteristics for user interface locations”, inventors Mohamed Abou Shousha and Amr Saad Mohamed Elsawy, assignee University of Miami, filed 2021-06-09, issued 2023-05-30.

Looked for and not found, or not quoted:

• openFDA 510(k) searches for applicant HERU and for device name Heru returned no matches (HTTP 404, message “No matches found”).
• An openFDA PMA search for applicant HERU returned no matches.
• An openFDA device-recall search for recalling firm HERU returned no matches.
• Direct requests to the Heru home page and to the site’s December 2020 registration post returned HTTP 403, so those pages are not quoted. A web search showed a BusinessWire item about a seed round and a Class I visual-field listing. That page was not opened, so the dollar figure and the spinout claim are not stated.
• The paper’s footnote says: “United States Patents (Application No. 17/083,043 and 17/392,664). Patents are owned by the University of Miami and licensed to Heru, Inc.” Those application numbers were not checked against the two patents above. No other partnership page was opened.
• No social-media post was opened.