Projector, Ophthalmic
An Ophthalmic Projector is a diagnostic device used in optometry and ophthalmology to project standardized optotype charts or test patterns onto a screen or wall for assessing visual acuity, refractive error, and other visual functions during eye examinations. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification or approval. It carries product code HOS and is regulated under 21 CFR 886.1680, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HOS
- Device Class
- FDA class 1
- Regulation Number
- 886.1680
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K936200 | WIRELESS CHART PROJECTOR,HCP-W 721 | Sep 28, 1994 | Substantially Equivalent | Canon USA, Inc. |
| K930443 | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | Jul 06, 1993 | Substantially Equivalent | Marco Ophthalmic, Inc. |
| K924784 | BURTON PROJECTOR HEAD - MODEL 6000-H | Apr 05, 1993 | Substantially Equivalent | R.H. Burton Co. |
| K921214 | OPHTHALMIC PROJECTOR | Jun 11, 1992 | Substantially Equivalent | Luneau Ophtalmologie SA |
| K890992 | WOODLYN OPHTHALMIC PROJECTOR | May 17, 1989 | Substantially Equivalent | Woodlyn, Inc. |
| K862519 | BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR | Jul 23, 1986 | Substantially Equivalent | Bausch & Lomb, Inc. |
| K812706 | MILLER/NADLER GLARE TESTER | Nov 16, 1981 | Substantially Equivalent | Mosebach Electric & Supply |
| K811180 | ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ | May 15, 1981 | Substantially Equivalent | American Optical Corp. |
| K781658 | PROJECTOR, ACCU-CHART ACUITY | Oct 17, 1978 | Substantially Equivalent | Bausch & Lomb, Inc. |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.