Atlas FDA

HOX

32 FDA 510(k) clearances · Product code

62 daysmedian time to decision
106 days90th percentile
32clearances measured

FDA profile

Official device name
Chart, Visual Acuity
Device class
Class I (low risk)
Regulation
21 CFR 886.1150
Medical specialty
Ophthalmic
Flags
GMP exempt
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CENTRAL VISION ANALYZER MODEL 1000 (K100095)Vimetrics,Llc.2010-05-10
HEINE LAMBDA 100 (K944156)Heine USA , Ltd.1995-01-12
OCCU-TECH VISION TEST (K881971)Applied Vision Concepts, Inc.1988-11-25
PL 20/20 INFANT VISION TESTER (K883337)Optimed Technologies, Inc.1988-10-31
VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE (K882634)Vistech Consultants, Inc.1988-07-15
PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM (K881358)Neuroscientific Corp.1988-06-27
MCT 8000 (MULTI-VISION CONTRAST TESTER) (K881059)Vistech Consultants, Inc.1988-04-04
VCTS 700S SYSTEM (K881021)Vistech Consultants, Inc.1988-04-01
VCTS 6500 SYSTEM (K881023)Vistech Consultants, Inc.1988-04-01
VCTS MARKETING PROGRAM SYSTEM (K881022)Vistech Consultants, Inc.1988-04-01
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (K880647)Fred Sammons, Inc.1988-04-01
OPTEC 1000 DMV VISION TESTER MODIFY (K875237)Stereo Optical Co., Inc.1988-03-17
MENTOR B-VAT(TM) II VIDEO TESTER (K875112)Mentor O & O, Inc.1988-03-08
'E' CUBE AND 'E' PAD (K873916)Richmond Products, Inc.1987-12-11
READING CHARTS-CARDS (DISTANCE AND NEARPOINT) (K873909)Richmond Products, Inc.1987-10-28
OPTEC 1000 DMV (K863509)Stereo Optical Co., Inc.1986-11-10
CANON AUTO ACUITOMETER CV-10 (K861416)Canon USA, Inc.1986-05-14
OPTRONICS CONTRAST ACUITY TESTER (K854983)Optronics, Inc.1986-02-04
IN-HOME VISION MONITORING KIT (K854047)Rich-Larky Company, Inc.1985-12-13
MENTOR BRIGHTNESS ACUITY TESTER (K853736)Mentor O & O, Inc.1985-11-01
VISTECH VCTS GLARE TESTER (K853481)Vistech Consultants, Inc.1985-10-29
VISTECH VCTS 6000 (K840255)Vistech Consultants, Inc.1984-04-13
ERGO DIAGNOSTIC CARD (K834145)American Ergo Systems1984-03-16
DOT VISUAL ACVITY TEST 2000 (K833956)Good-Lite Co.1984-01-04
TESTING VISUAL ACUITY (K833778)Technical Enginuities Co.1984-01-04
VFS 1000/SCREENING FUNCTION ANALYZER (K830011)CooperVision, Inc.1983-01-17
NIC OPTRONICS CS-2000 (K822215)Nicolet Biomedical Instruments1982-08-31
MENTOR POTENTIAL ACUITY METER (K821932)Mentor O & O, Inc.1982-08-03
EYE CHARTS (K813376)Abco Dealers, Inc.1982-01-07
EYETECH-VISION SCREENING SYSTEM (K803256)Eyedex1981-03-04
OPHTHALMIC DRESSING TRAY (K790909)Pent-Cal, Inc.1979-08-03
BAYLOW VISUAL ACUITY TESTER (K781452)Codman & Shurtleff, Inc.1978-10-24

Track HOX automatically

Every clearance here is in the API, with alerts when new ones post.