Product Code: HOJ FDA class 1 21 CFR 886.1810

Screen, Tangent, Target

Ophthalmic

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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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.

1418300: 16 registrations

Registration Numbers

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.

1418300: 16 registrations