Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1680](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1680) → HOS — Projector, Ophthalmic

# HOS · Projector, Ophthalmic

_Ophthalmic · 21 CFR 886.1680 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS

## Overview

- **Product Code:** HOS
- **Device Name:** Projector, Ophthalmic
- **Regulation:** [21 CFR 886.1680](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1680)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ophthalmic projector is an AC-powered device intended to project an image on a screen for vision testing.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K936200](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS/K936200.md) | WIRELESS CHART PROJECTOR,HCP-W 721 | Canon USA, Inc. | Sep 28, 1994 | SESE |
| [K930443](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS/K930443.md) | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | Marco Ophthalmic, Inc. | Jul 6, 1993 | SESE |
| [K924784](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS/K924784.md) | BURTON PROJECTOR HEAD - MODEL 6000-H | R.H. Burton Co. | Apr 5, 1993 | SESE |
| [K921214](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS/K921214.md) | OPHTHALMIC PROJECTOR | Luneau Ophtalmologie SA | Jun 11, 1992 | SESE |
| [K890992](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS/K890992.md) | WOODLYN OPHTHALMIC PROJECTOR | Woodlyn, Inc. | May 17, 1989 | SESE |
| [K862519](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS/K862519.md) | BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR | Bausch & Lomb, Inc. | Jul 23, 1986 | SESE |
| [K812706](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS/K812706.md) | MILLER/NADLER GLARE TESTER | Mosebach Electric & Supply | Nov 16, 1981 | SESE |
| [K811180](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS/K811180.md) | ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ | American Optical Corp. | May 15, 1981 | SESE |
| [K781658](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS/K781658.md) | PROJECTOR, ACCU-CHART ACUITY | Bausch & Lomb, Inc. | Oct 17, 1978 | SESE |

## Top Applicants

- Bausch & Lomb, Inc. — 2 clearances
- American Optical Corp. — 1 clearance
- Canon USA, Inc. — 1 clearance
- Luneau Ophtalmologie SA — 1 clearance
- Marco Ophthalmic, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOS)

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