Two shapes on one FDA list

Judgment

Same FDA list, two different shapes.

Heru looks like nine Class I exam codes for one wearable exam.

Warby Parker looks like an eyewear company that later listed a prescription-renewal acuity test beside frames and sunglasses.

How Miru got there

1. Start from one product code. Both companies are on the saved 16 September 2026 list for QTO (digital visual acuity tests), among 27 makers.
2. Read everything else each company registered. Heru’s establishment has nine device listings; Warby Parker’s has three (checked 2026-10-02).
3. See what those listings are. Heru’s are all eye tests, from a visual-field test in 2020 to a refractometer in 2025. Warby Parker’s are spectacle frames (2009) and sunglasses (2020), then the acuity test (2023).
4. Check what role the company plays. For frames and sunglasses, Warby Parker relabels and sets specifications rather than manufacturing at that establishment; for the acuity test, it is the manufacturer.
5. Judge the shape. Nine eye tests from one maker look like one wearable exam (a 2023 Journal of Glaucoma paper describes the visual-field piece as headset software; it does not show the other eight run on the headset). An eyewear company that later made one acuity test looks like a prescription-renewal app added to an eyewear business (its overview PDF reads Prescription Check and Virtual Vision Test as old and new names of one app).

What this comparison leaves out

This page is one code, QTO, from the saved 16 September 2026 list of 27 makers, not the whole FDA catalog. It shows Heru and Warby Parker because the point is the contrast in shape, not a ranking of the other 25. The 16 September 2026 list and the listing check on 2026-10-02 are a snapshot, not a live search. Searches of the FDA's clearance (510(k)) and approval (PMA) records found no match for either company, so this page does not claim either device is FDA-cleared. The 2023 headset paper covers Heru's visual-field test only; it does not show the other eight Heru codes run on the headset.

Heru

The openFDA registration listing for establishment FEI 3017657497, checked 2026-10-02 UTC, returned nine records, all named HERU, INC., at 201 S Biscayne Blvd Suite 2866, Miami, FL 33131. Dates in this list are the date on the listing. Proprietary names are the names on that listing. Device names are the openFDA classification names for those product codes.

1. HPT — Heru Visual Field — 2020-11-24. Perimeter, Automatic, Ac-Powered. Class 1, regulation 886.1605. 21 CFR 886.1605 (2024) says: “A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient.”
2. HIT — 2022-08-15. The listing names Heru Color Vision Test — Ishihara, and Heru Color Vision Test — D-15. Device name: Tester, Color Vision.
3. HOX — Heru Contrast Sensitivity — 2022-08-15. The trade name says contrast sensitivity. The product-code description is 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. The trade name on the listing and the product-code name are not the same description.
4. OUM — Heru Dark Adaptation — 2022-08-15. Device name: Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation.
5. QTO — no proprietary name — 2023-03-28. Device name: Digital Visual Acuity Test.
6. HLG — no proprietary name — 2023-03-28. Device name: Pupillometer, Ac-Powered.
7. HJS — Heru Eye Motility — 2023-03-30. Device name: Test, Spectacle Dissociation, Ac-Powered (Lancaster).
8. HJQ — Heru Cover Test — 2023-03-30. Device name: Stereoscope, Ac-Powered.
9. HKO — Heru Refract — 2025-07-01. Device name: Refractometer, Ophthalmic.

A 2023 paper describes the visual-field piece 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. The journal paper is not claimed to prove the other eight codes run on the headset.

The longer Heru trail is on the Heru page.

Warby Parker

The openFDA registration listing for establishment FEI 3007808885, checked 2026-10-02 UTC, returned three records, all named Warby Parker, at 233 Spring Street, 6th Floor East, New York, NY 10013. Dates, proprietary names, and establishment types in this list are from that listing. Device names are the openFDA classification names for those product codes.

1. HQZ — spectacle frames — proprietary name Warby Parker — 2009-07-16. Device name: Frame, Spectacle. Class 1, regulation 886.5842. Establishment types on this row: Repack or Relabel Medical Device, and Develop Specifications But Do Not Manufacture At This Facility. Those are repack-or-relabel and specification-developer rather than manufacture. 21 CFR 886.5842 (2024) says: “A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.”
2. HQY — non-prescription sunglasses — proprietary name Warby Parker — 2020-04-10. Same New York establishment on that listing. Device name: Sunglasses (Non-Prescription Including Photosensitive). This row has those same two establishment types: repack-or-relabel and specification-developer rather than manufacture.
3. QTO — Prescription Check and Virtual Vision Test — 2023-12-14. Same New York establishment on that listing. Device name: Digital Visual Acuity Test. This row’s establishment type is only Manufacture Medical Device.

The overview PDF says: “Virtual Vision Test by Warby Parker is an update (a big update!) to our telehealth prescription renewal app, previously called Prescription Check.” Source: virtual-vision-test-overview.pdf. That sentence is quoted as it appears. It reads those two names as the old and new names of one prescription-renewal app.

The openFDA listing for FEI 3007808885 has no refractometer product code.

Sources, including what was not found

Heru dates, names, and empty clearance fields: the openFDA registration listing for establishment FEI 3017657497, named at the top of the block. The device list uses that listing. The HPT line cites 21 CFR 886.1605 (2024). The HOX line cites 21 CFR 886.1150 (2024). The headset sentence: Journal of Glaucoma, 2023;32(8):647–657. The QTO snapshot of 2026-09-16 lists HERU, INC. in Miami, FL, as one of the 27 makers. Source: the saved 16 September 2026 QTO company list.

Looked for and not found for Heru, from those openFDA searches:

• openFDA 510(k) searches for applicant HERU and for device name Heru returned no 510(k) match (HTTP 404, message “No matches found”).
• No PMA match. A search for applicant HERU returned no matches.
• No recall match. A device-recall search for recalling firm HERU returned no matches.

Warby dates, names, roles, and empty clearance fields: the openFDA listing for FEI 3007808885. The HQZ identification: 21 CFR 886.5842 (2024), cited above. The rename sentence: the overview PDF cited above. The terms of use are not proof of a missing refractometer registration. The QTO snapshot of 2026-09-16 lists Warby Parker in New York, NY, as one of the 27 makers. Source: the saved 16 September 2026 QTO company list.

Looked for and not found for Warby Parker, from those openFDA searches:

• openFDA 510(k) searches for applicant Warby, for device name Prescription Check, and for device name Virtual Vision returned no 510(k) match (HTTP 404, message “No matches found”).
• No PMA match. A search for applicant Warby returned no matches.
• No recall match. A device-recall search for recalling firm Warby returned no matches.