Written and maintained by CASRAI Editorial Board
Last updated
Ptosis glasses are spectacles fitted with a ptosis crutch, a device mounted on the frame to hold a drooping upper eyelid open. In US federal regulation the device is a Class I ophthalmic therapeutic device, product code HJZ, listed at 21 CFR 886.5600. This guide is general product and regulatory information for lab, clinic and supply staff; it is not medical advice, and decisions about an individual’s eyelid belong with an eye care professional.
Short answer
“Ptosis glasses” is the everyday name for spectacles carrying a ptosis crutch. The Code of Federal Regulations defines a ptosis crutch as a device intended to be mounted on the spectacles of a patient who has ptosis to hold the upper eyelid open. FDA classifies it as Class I (general controls) and exempts it from premarket notification. The crutch holds the lid; it is not a lens and it does not address the cause of the droop.
Definition and scope
Ptosis is a drooping of the upper eyelid. The American Academy of Ophthalmology describes it as the upper eyelid drooping over the eye, which may be slight or may cover the pupil and block vision. In children it is often congenital and linked to problems with the levator muscle; in adults it is usually related to aging or injury, sometimes follows eye surgery, and is rarely caused by disease or a tumor.
The regulation uses the same framing: the ptosis crutch is intended for a patient with ptosis, described in the rule as drooping of the upper eyelid as a result of faulty development or paralysis, and its stated function is to hold the upper eyelid open. The regulatory text defines the device by what it is mounted on (spectacles) and what it does (holds the lid open).
How the device is described in practice
At the level of its regulatory identification, the device is mounted on spectacles and holds the upper lid open. Because it is carried by the frame, it is part of the spectacle assembly; the general anatomy of a frame is covered in parts of eyeglasses and lens options in types of eyeglass lenses. Fitting, adjustment and the suitability of a crutch for any one person are clinical and optical decisions made by the treating professional, and are outside the scope of this page.
Where it matters for labs, clinics and supply decisions
For staff who classify or catalogue devices, the regulatory record is the useful fact base. The records below were checked on 2026-10-31.
- Regulation: 21 CFR 886.5600, Part 886 (Ophthalmic Devices), Subpart F (Therapeutic Devices).
- Class: Class I (general controls).
- Premarket notification: exempt from the 510(k) requirements of subpart E of part 807, subject to the limitations in 21 CFR 886.9. An FDA search of 510(k) records for product code HJZ returns no matches, which is consistent with that exemption, so there is no 510(k) number to look up for this device type.
- Quality system: exempt from part 820 except for the records and complaint-file requirements (820.35). The FDA classification database flags the product code as exempt from good manufacturing practice (gmp_exempt_flag Y).
- Product code: HJZ, device name “Crutch, Ptosis”, medical specialty Ophthalmic, not an implant, summary malfunction reporting eligible.
Checking an item against these records means matching the device description and product code, not looking for a clearance number. Related pages on the site cover neighbouring ophthalmic equipment: ophthalmic surgical instruments, the eyelid speculum and what ophthalmology covers.
Common misunderstandings
It is not a lens
The regulation describes a device mounted on the spectacles to hold the lid open. It makes no statement about optical power, so ptosis glasses should not be confused with corrective lenses.
Class I does not mean “no rules”
Class I devices are subject to general controls. The 510(k) exemption removes the premarket notification step; it does not remove the record and complaint-file requirements noted above.
The crutch is not an implant
The classification record for HJZ marks the device as not an implant; it is carried on the spectacles.
FAQ
What are ptosis glasses?
Spectacles carrying a ptosis crutch, a device that holds a drooping upper eyelid open, as defined in 21 CFR 886.5600.
Is a ptosis crutch regulated by FDA?
Yes. It is a Class I device under 21 CFR 886.5600, product code HJZ, exempt from 510(k) premarket notification.
What is the product code for a ptosis crutch?
HJZ, listed in the FDA classification database as “Crutch, Ptosis” under the ophthalmic specialty.
Do ptosis glasses treat the cause of ptosis?
The regulatory definition describes holding the upper eyelid open, not treating the cause. An eye care professional decides what applies to an individual.
Sources
- 21 CFR 886.5600, Ptosis crutch (Legal Information Institute copy of the e-CFR), checked 2026-10-31.
- openFDA device classification, regulation 886.5600 (index updated 2026-10-19), checked 2026-10-31.
- American Academy of Ophthalmology, What Is Ptosis? (used for the description of ptosis only), checked 2026-10-31.
