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Bioptic Glasses: What They Are and Their FDA Class

Bioptic glasses carry a small telescope on the frame or lens. See how they are used, their FDA Class I status and why driving rules are set by states.

Written and maintained by CASRAI Editorial Board

Last updated

General information only, not medical advice. Whether a bioptic device suits a person, and whether they may drive with one, is decided by their eye-care professional and their licensing authority.

Short answer

Bioptic glasses are ordinary eyeglasses with a small telescope mounted on the frame or set into the upper part of the lens. The wearer looks through their regular lens most of the time and tilts the head to look briefly through the telescope at distant detail. In the United States the device is regulated as a low-vision telescope: Class I under 21 CFR 886.5870. That federal status says nothing about driving eligibility, which states decide.

Definition and scope

A bioptic telescope system is a small magnifying telescope mounted on a pair of eyeglasses, either attached to the top of the frame or set into the upper part of the lens (Chun, Cucuras and Jay, 2016). “Bioptic telescope”, “telescopic glasses” and “bioptic glasses” are everyday names for this spectacle-mounted device.

The federal regulation does not use the word “bioptic”. It defines a low-vision telescope as “an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects”, and says the generic type “includes handheld or spectacle telescopes” (21 CFR 886.5870, checked 2026-10-31). A bioptic is therefore the spectacle form of this device type.

How it is used in practice

According to the 2016 review in Neuro-Ophthalmology, the wearer views through their spectacle correction the majority of the time. To spot a detail at a distance, such as a sign or a pedestrian, they tilt the head to bring the telescope into the line of sight for a brief look, then return to the regular lens. The magnifying telescope is an aid for spotting and identifying; it is not worn as the main viewing path.

Driving with bioptics is the use that has drawn most research and regulation. Owsley (2012) notes that under most states’ vision standards, a person with acuity worse than 20/40 is turned away through regular licensing, that bioptic telescope licensing programs and devices have existed since the 1970s, and that rigorous scientific study of driving with them is limited. This page does not describe how to obtain a license or any training requirements.

Types and related concepts

Spectacle-mounted and handheld telescopes

The regulation groups handheld and spectacle telescopes under one device type. Bioptic glasses are the spectacle type. A handheld telescope is held to the eye for a specific task and is a different arrangement from a head-worn bioptic. For non-telescopic handheld magnification, see the guide to the handheld magnifier.

Frame-mounted and lens-embedded

The review describes two mounting positions: attached to the top of the frame, or set into the upper part of the lens. For the parts of the frame and lens a telescope attaches to, see parts of eyeglasses.

Where it matters for labs, clinics and supply decisions

The table sets out what the regulation states and what the regulation and the cited papers state. It is an orientation aid for staff who document or categorise these devices, not a selection guide.

Question What the source states Source
What is the device type? A low-vision telescope: lenses or mirrors to increase the apparent size of objects for a patient with impaired vision; includes handheld or spectacle telescopes 21 CFR 886.5870
FDA classification? Class I (general controls) 21 CFR 886.5870
Premarket notification? Exempt from 510(k) (subpart E of part 807), subject to the limitations in 886.9 21 CFR 886.5870
Quality system rules? Exempt from part 820 except records (820.35) and complaint files 21 CFR 886.5870
Does the regulation set a magnification or optical performance standard? No performance standard appears in the regulation text 21 CFR 886.5870
Does the federal classification decide who may drive with one? No. The cited papers describe driving as governed by state vision standards and state bioptic programs Owsley 2012; Chun et al. 2016

For how Class I, 510(k) exemption and other classes relate, see FDA medical device classification: 510(k) and PMA, FDA 510(k) premarket notification and what is a medical device.

How the published state counts differ

Sources disagree on how many US states allow bioptic driving because they were written at different times. Owsley (2012) reports that more than 40 states run bioptic telescope licensing programs. Chun and colleagues (2016) state that 45 states allowed bioptic driving, that Utah, Iowa, Connecticut, Maine and the District of Columbia prohibited it, and that Minnesota decided case by case. Treat any count as dated; the current rule is set by the state licensing agency.

Common misunderstandings

  • “Class I means approved for driving.” Class I is an FDA device classification with general controls. Driving eligibility is a separate state matter.
  • “Bioptics replace regular glasses.” Per the 2016 review, the wearer looks through the regular spectacle correction most of the time and uses the telescope briefly.
  • “Bioptic glasses and a handheld magnifier are the same thing.” The regulation covers telescopes, handheld or spectacle; a bioptic is the spectacle form, worn on the head.
  • “The risks are settled.” Some researchers have raised the ring scotoma as a concern; the 2016 review presents it as a concern, not a settled finding, and Owsley notes limited rigorous study overall.
  • “Licensing depends only on the device.” Chun and colleagues state that most US states require a minimum 20/40 visual acuity and 120 to 140 degrees of total visual field for full-time licensing; for how acuity is charted, see the Snellen chart guide.

FAQ

What are bioptic glasses?

Eyeglasses with a small telescope mounted on the frame or set into the upper part of the lens, used briefly to see distant detail while the regular lens is used most of the time.

Is a bioptic telescope the same as telescopic glasses?

Both phrases describe a telescope worn on spectacles, the spectacle type covered by 21 CFR 886.5870.

How does FDA regulate bioptic glasses?

As a low-vision telescope: Class I, exempt from 510(k) premarket notification subject to the limitations in 886.9, and exempt from part 820 except records and complaint files (21 CFR 886.5870, checked 2026-10-31).

Can someone drive with bioptic glasses?

That is decided by each state’s licensing rules, not by FDA classification. Published counts of permitting states differ by date (more than 40 per Owsley 2012; 45 per Chun et al. 2016). The state licensing agency and the person’s eye-care professional decide.

Sources

  • 21 CFR 886.5870, Low-vision telescope, Legal Information Institute: law.cornell.edu/cfr/text/21/886.5870 (checked 2026-10-31).
  • Owsley C. Driving with bioptic telescopes: organizing a research agenda. Optom Vis Sci. 2012;89(9):1249-56: PubMed 22863791 (checked 2026-10-31).
  • Chun R, Cucuras M, Jay WM. Current perspectives of bioptic driving in low vision. Neuro-Ophthalmology. 2016: PMC5123033 (checked 2026-10-31).

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