Product Code: HOX FDA class 1 21 CFR 886.1150

Chart, Visual Acuity

Ophthalmic

A Visual Acuity Chart is a standardized diagnostic ophthalmic device consisting of letters, numbers, or symbols of progressively decreasing size arranged in rows, used by clinicians to measure a patient's distance or near visual acuity as part of a routine eye examination or refraction. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HOX and is regulated under 21 CFR 886.1150, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.

View on FDA

510(k)s

FEI Numbers

106

Registration Numbers

107

Unique Applicants

Years Active

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Basic Information

Product Code: HOX
Device Class: FDA class 1
Regulation Number: 886.1150
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K100095	CENTRAL VISION ANALYZER MODEL 1000	May 10, 2010	Substantially Equivalent	Vimetrics,Llc.
K944156	HEINE LAMBDA 100	Jan 12, 1995	Substantially Equivalent	Heine USA , Ltd.
K881971	OCCU-TECH VISION TEST	Nov 25, 1988	Substantially Equivalent	Applied Vision Concepts, Inc.
K883337	PL 20/20 INFANT VISION TESTER	Oct 31, 1988	Substantially Equivalent	Optimed Technologies, Inc.
K882634	VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE	Jul 15, 1988	Substantially Equivalent	Vistech Consultants, Inc.
K881358	PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM	Jun 27, 1988	Substantially Equivalent	Neuroscientific Corp.
K881059	MCT 8000 (MULTI-VISION CONTRAST TESTER)	Apr 04, 1988	Substantially Equivalent	Vistech Consultants, Inc.
K881023	VCTS 6500 SYSTEM	Apr 01, 1988	Substantially Equivalent	Vistech Consultants, Inc.
K881022	VCTS MARKETING PROGRAM SYSTEM	Apr 01, 1988	Substantially Equivalent	Vistech Consultants, Inc.
K881021	VCTS 700S SYSTEM	Apr 01, 1988	Substantially Equivalent	Vistech Consultants, Inc.
K880647	ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)	Apr 01, 1988	Substantially Equivalent	Fred Sammons, Inc.
K875237	OPTEC 1000 DMV VISION TESTER MODIFY	Mar 17, 1988	Substantially Equivalent	Stereo Optical Co., Inc.
K875112	MENTOR B-VAT(TM) II VIDEO TESTER	Mar 08, 1988	Substantially Equivalent	Mentor O & O, Inc.
K873916	'E' CUBE AND 'E' PAD	Dec 11, 1987	Substantially Equivalent	Richmond Products, Inc.
K873909	READING CHARTS-CARDS (DISTANCE AND NEARPOINT)	Oct 28, 1987	Substantially Equivalent	Richmond Products, Inc.
K863509	OPTEC 1000 DMV	Nov 10, 1986	Substantially Equivalent	Stereo Optical Co., Inc.
K861416	CANON AUTO ACUITOMETER CV-10	May 14, 1986	Substantially Equivalent	Canon USA, Inc.
K854983	OPTRONICS CONTRAST ACUITY TESTER	Feb 04, 1986	Substantially Equivalent	Optronics, Inc.
K854047	IN-HOME VISION MONITORING KIT	Dec 13, 1985	Substantially Equivalent	Rich-Larky Company, Inc.
K853736	MENTOR BRIGHTNESS ACUITY TESTER	Nov 01, 1985	Substantially Equivalent	Mentor O & O, Inc.
K853481	VISTECH VCTS GLARE TESTER	Oct 29, 1985	Substantially Equivalent	Vistech Consultants, Inc.
K840255	VISTECH VCTS 6000	Apr 13, 1984	Substantially Equivalent	Vistech Consultants, Inc.
K834145	ERGO DIAGNOSTIC CARD	Mar 16, 1984	Substantially Equivalent	American Ergo Systems
K833956	DOT VISUAL ACVITY TEST 2000	Jan 04, 1984	Substantially Equivalent	Good-Lite Co.
K833778	TESTING VISUAL ACUITY	Jan 04, 1984	Substantially Equivalent	Technical Enginuities Co.
K830011	VFS 1000/SCREENING FUNCTION ANALYZER	Jan 17, 1983	Substantially Equivalent	CooperVision, Inc.
K822215	NIC OPTRONICS CS-2000	Aug 31, 1982	Substantially Equivalent	Nicolet Biomedical Instruments
K821932	MENTOR POTENTIAL ACUITY METER	Aug 03, 1982	Substantially Equivalent	Mentor O & O, Inc.
K813376	EYE CHARTS	Jan 07, 1982	Substantially Equivalent	Abco Dealers, Inc.
K803256	EYETECH-VISION SCREENING SYSTEM	Mar 04, 1981	Substantially Equivalent	Eyedex
K790909	OPHTHALMIC DRESSING TRAY	Aug 03, 1979	Substantially Equivalent	Pent-Cal, Inc.
K781452	BAYLOW VISUAL ACUITY TESTER	Oct 24, 1978	Substantially Equivalent	Codman & Shurtleff, Inc.