Screen, Tangent, Target
A Tangent Target Screen is a diagnostic ophthalmic device consisting of a flat surface with a fixation point and marked targets used to map the central visual field and detect scotomas or other visual field defects through a manual perimetry technique. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification or approval. It carries product code HOJ and is regulated under 21 CFR 886.1810, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HOJ
- Device Class
- FDA class 1
- Regulation Number
- 886.1810
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K873919 | TANGENT SCREEN | Oct 28, 1987 | Substantially Equivalent | Richmond Products, Inc. |
| K844657 | SPECTABLE FRAME MAGNIFYING BRILLETTE | Dec 11, 1984 | Substantially Equivalent | Pro Design Intl. AS |
| K821081 | CHART PROJECTOR | Jun 14, 1982 | Substantially Equivalent | Medical Equipment Designs, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.