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HOX — Chart, Visual Acuity Class I

FDA Device Classification

FDA product code HOX covers "Chart, Visual Acuity", a Class I medical device regulated under 21 CFR 886.1150. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HOX
Device Class
Class I
Regulation Number
886.1150
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K100095vimetricsCENTRAL VISION ANALYZER MODEL 1000May 10, 2010
K944156heine usaHEINE LAMBDA 100January 12, 1995
K881971applied vision conceptsOCCU-TECH VISION TESTNovember 25, 1988
K883337optimed technologiesPL 20/20 INFANT VISION TESTEROctober 31, 1988
K882634vistech consultantsVISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLAREJuly 15, 1988
K881358neuroscientificPG CONSEN CONTRAST SENSITIVITY TESTING PROGRAMJune 27, 1988
K881059vistech consultantsMCT 8000 (MULTI-VISION CONTRAST TESTER)April 4, 1988
K881023vistech consultantsVCTS 6500 SYSTEMApril 1, 1988
K881021vistech consultantsVCTS 700S SYSTEMApril 1, 1988
K881022vistech consultantsVCTS MARKETING PROGRAM SYSTEMApril 1, 1988
K880647fred sammonsADULT PERCEPTUAL MOTOR PUZZLES (5331-01)April 1, 1988
K875237stereo optical coOPTEC 1000 DMV VISION TESTER MODIFYMarch 17, 1988
K875112mentor o and oMENTOR B-VAT(TM) II VIDEO TESTERMarch 8, 1988
K873916richmond products'E' CUBE AND 'E' PADDecember 11, 1987
K873909richmond productsREADING CHARTS-CARDS (DISTANCE AND NEARPOINT)October 28, 1987
K863509stereo optical coOPTEC 1000 DMVNovember 10, 1986
K861416canon usaCANON AUTO ACUITOMETER CV-10May 14, 1986
K854983optronicsOPTRONICS CONTRAST ACUITY TESTERFebruary 4, 1986
K854047rich-larky companyIN-HOME VISION MONITORING KITDecember 13, 1985
K853736mentor o and oMENTOR BRIGHTNESS ACUITY TESTERNovember 1, 1985

FDA data resources