Quick facts
- A fornixscope is a small instrument used to pull back and hold open the eyelid so that the conjunctiva can be examined.
- In the United States it files under 21 CFR 886.1320, Fornixscope, at Class I, product code HKG.
- Canada keeps no named entry. The instrument is non-invasive — it retracts the eyelid rather than coming into contact with the surface of the eye — so Rule 7(1) of Schedule 1 keeps it at Class I.
- The near miss is Rule 2(1), which lifts any invasive device that comes into contact with the surface of the eye to Class II; the identification is what keeps the fornixscope out of it.
- Both countries therefore answer Class I, but by different routes: a named entry in one and a non-invasive default in the other.
- Entries, classes and product codes below were checked against the eCFR, the Regulations and the openFDA classification database on 2026-10-14.
A fornixscope is the small retractor used to examine the conjunctival fornix: it pulls the eyelid back and holds it open so the clinician can see the tissue that runs between the lid and the globe. It is a hand instrument, it is used at the slit lamp, and it is one of the ophthalmic devices most often misread as touching the eye. The United States names it at Class I; Canada reaches Class I through the non-invasive default, and this article sets out why the eye-contact rule does not capture it — with the hypoallergenic paper tape a treatment room keeps at the same station.
What is a fornixscope?
It is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva. In practice it is a small fenestrated retractor: the clinician places it against the lid margin, draws the lid back, and the window in the instrument lets the conjunctival surface be inspected with the slit lamp while the lid is held clear of the globe.
The instrument is used in the assessment of conjunctival disease and in fitting and checking ocular prostheses and shells, where the fornix depth and the state of the conjunctival sac have to be seen. Because it is reused on many patients, the routine that matters for the clinic is the one that sits around it: cleaning and reprocessing between patients, and a record that the loop was closed.
What class is a fornixscope in the United States?
It is a named entry at Class I. 21 CFR 886.1320 is titled Fornixscope, and the identification reads: "A fornixscope is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva." The device is exempt from the premarket notification procedures in subpart E of part 807, and it is also exempt from the quality management system requirements of part 820 except for the requirements on records and complaint files.
The openFDA device classification API lists product code HKG against 886.1320. The entry is a good example of a Class I ophthalmic device that is nonetheless a reusable, patient-contact instrument: the low class attaches to the low risk of a lid retractor, not to the fact that it is sterilised between uses.
| Item | Detail |
|---|---|
| US regulation | 21 CFR 886.1320 - Fornixscope |
| US class | Class I (general controls) |
| Product code | HKG |
| Route to market | Exempt from premarket notification under subpart E of part 807; exempt from part 820 except records and complaint files |
| Stated intended use | To pull back and hold open the eyelid to aid examination of the conjunctiva |
| Single use or reusable | Reusable; the entry itself says nothing about reprocessing |
How does Canada classify a fornixscope?
Canada keeps no named entry. It applies the classification rules in Schedule 1 of the Medical Devices Regulations, and the answer turns on whether the instrument is invasive. Rule 2(1) is the rule a reader usually reaches for first: "Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II." Read only that far, and an ophthalmic instrument looks like a Class II device.
The identification is what settles it. The device is described as one that pulls back and holds open the eyelid; it is not described as coming into contact with the surface of the eye. A lid retractor acts on the lid, not on the globe, so it is a non-invasive device, and the governing rule is Rule 7(1): "Subject to subrule (2), all other non-invasive devices are classified as Class I." That is the same class the United States gives it, reached by the opposite route.
| Item | Canada | United States |
|---|---|---|
| Named entry | None; classified by rule | 886.1320 - Fornixscope |
| Class | Class I (Rule 7(1), non-invasive) | Class I (general controls) |
| Governing text | Schedule 1, Part 1, Rule 7(1) | 21 CFR 886.1320 |
| Near miss | Rule 2(1) would give Class II if the device came into contact with the surface of the eye | Not applicable |
| Route to market | Class I obligations under the Regulations | Exempt from premarket notification, subject to section 886.9 |
Does a Class I device still need reprocessing between patients?
That is the practical question a clinic actually faces, and the answer sits outside the class. A Class I device can still be a critical instrument in the clinic's own process: it is a reusable instrument that contacts mucous membrane and the lid margin, so the practice treats it as an instrument to be cleaned and reprocessed between patients, exactly as it would a more heavily regulated instrument.
The class tells the buyer who reviews the device before it reaches the market; it does not tell the clinic how to clean it. The maker's processing instructions are what the clinic follows, and the record that the loop was closed is what an auditor asks for. A practice that keeps the reprocessing record beside the instrument's identity can answer the question when it comes. That is why the instrument's class and the clinic's routine are two separate conversations, even where both land on Class I.
What should a clinic check before ordering one?
Three checks. First, confirm the intended-use statement on the labelling matches the instrument itself, because the US entry and the Canadian reading both key off that description. Second, confirm the maker's reprocessing instructions, since a Class I reusable instrument still has to be cleaned and sterilised the way the maker says. Third, confirm the window size and the length the clinic needs, because a fornixscope used for conjunctival inspection and one used for shell fitting are different fittings of the same instrument.
An eye clinic reorders the consumables that sit at the same slit-lamp station. Clinics that stock for a whole practice can order through the wholesale programme and request a bulk quote for a standing or annual order; the hypoallergenic paper tape sits in the same catalogue. Reselling? become a distributor.
Why is the eye-contact rule the wrong one to apply here?
Because "ophthalmic" and "comes into contact with the surface of the eye" are not the same thing, and the regulation text is careful about the difference. Rule 2(1) reaches devices that penetrate a body orifice or touch the surface of the eye; the fornixscope does neither. It is the neighbouring rule, Rule 7(1), that governs a device of this shape.
The same distinction runs through the rest of the ophthalmic list. A contact lens, a corneal electrode and a goldmann-type contact prism all touch the globe and are read against Rule 2; a trial frame, a visual-acuity chart and a lid retractor do not, and are read against Rule 7. Getting the contact question right is what makes the class right.
Sources
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- US FDA, medical device databases
- US FDA, overview of device regulation
- Health Canada, medical devices
- Health Canada, establishment licensing
- Standards Council of Canada
- CSA Group
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, application of risk management to medical devices
- ISO 15004-1:2020, ophthalmic instruments, general requirements
- ISO 17664:2017, processing of health care products, information to be provided
- Canadian Association of Optometrists
- College of Optometrists of Ontario, standards of practice
- Canadian Ophthalmological Society
- CCOHS, OSH answers
- Health Canada, medical device licence application guidance
One sheet for the reusable-instrument loop. A retractor that goes back into the tray after every patient needs a record that says what was cleaned, when, and by whom. The compliance log centre carries a blank reprocessing-room sheet and an equipment-maintenance sheet you can print, and you can run as many copies as the clinic has stations. No account and no sign-up.
Date the sheet once and reuse the layout. Enter the practice name and the bench once, and the sterilization log generator returns a dated sheet with the cycle columns already laid out, ready to print and clip into the quality folder.
Ask a compliance specialist. A classification question usually turns on how the device is used, not only on its name. Ask a compliance specialist — you get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Ophthalmic specula in Canada vs the US
- Slit lamps in Canada vs the US
- Ophthalmic sponges in Canada vs the US
CliniEco Medical supplies eye care, laboratory and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and dental procurement professionals and is not legal advice; the class of a device and the records a practice keeps belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
What class is a fornixscope in the United States?
Class I under 21 CFR 886.1320, product code HKG, exempt from premarket notification subject to the limits of section 886.9.
What class is it in Canada?
Class I, under Rule 7(1) of Schedule 1 of the Medical Devices Regulations, which is the default for non-invasive devices.
Does the eye-contact rule apply to it?
No. Rule 2(1) lifts devices that touch the surface of the eye to Class II. The fornixscope retracts the eyelid rather than touching the globe, so it stays non-invasive.
Do the two countries agree?
On the class, yes — both say Class I. The routes differ: the United States has a named entry, while Canada derives the class from a rule.
Is it still reprocessed between patients?
Yes. A Class I reusable instrument that contacts the lid margin and mucous membrane is cleaned and reprocessed between patients, following the maker's instructions, and the clinic records that the loop was closed.
Does the class change the price or the paperwork?
Not directly. The class sets who reviews the device before it reaches the market. The clinic's own paperwork — the reprocessing record and the maintenance sheet — is set by the practice and by the maker's instructions.
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