HOS · Projector, Ophthalmic
Ophthalmic · 21 CFR 886.1680 · Class 1
Overview
| Product Code | HOS |
|---|---|
| Device Name | Projector, Ophthalmic |
| Regulation | 21 CFR 886.1680 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Cleared Devices (9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K936200 | WIRELESS CHART PROJECTOR,HCP-W 721 | Canon USA, Inc. | Sep 28, 1994 | SESE |
| K930443 | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | Marco Ophthalmic, Inc. | Jul 6, 1993 | SESE |
| K924784 | BURTON PROJECTOR HEAD - MODEL 6000-H | R.H. Burton Co. | Apr 5, 1993 | SESE |
| K921214 | OPHTHALMIC PROJECTOR | Luneau Ophtalmologie SA | Jun 11, 1992 | SESE |
| K890992 | WOODLYN OPHTHALMIC PROJECTOR | Woodlyn, Inc. | May 17, 1989 | SESE |
| K862519 | BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR | Bausch & Lomb, Inc. | Jul 23, 1986 | SESE |
| K812706 | MILLER/NADLER GLARE TESTER | Mosebach Electric & Supply | Nov 16, 1981 | SESE |
| K811180 | ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ | American Optical Corp. | May 15, 1981 | SESE |
| K781658 | PROJECTOR, ACCU-CHART ACUITY | Bausch & Lomb, Inc. | Oct 17, 1978 | SESE |
Top Applicants
- Bausch & Lomb, Inc. — 2 clearances
- Woodlyn, Inc. — 1 clearance
- R.H. Burton Co. — 1 clearance
- Mosebach Electric & Supply — 1 clearance
- Marco Ophthalmic, Inc. — 1 clearance
