Atlas FDA

HKO

35 FDA 510(k) clearances · Product code

75 daysmedian time to decision
194 days90th percentile
35clearances measured

FDA profile

Official device name
Refractometer, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.1760
Medical specialty
Ophthalmic
Adverse events (MAUDE)
2012: 17 · 2016: 9 · 2017: 10 · 2024: 28 · 2025: 37 · 2026: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (K031831)Topcon Medical Systems, Inc.2003-12-19
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 (K000327)Visx, Incorporated2000-05-02
DIGITAL RETINOSCOPIC PHOTOMETER (K951179)Kudi Kalu, Inc.1995-05-30
VIDEO VISION ANALYZER (VIVA), VRB 100 (K945959)Tomey Corporation USA1995-03-01
AUTO REF-KERATOMETER, RK-3 (K942242)Cannon U.S.A., Inc.1994-09-02
AUTO REFF-30 (K940516)Canon, Inc.1994-07-12
AUTOREF LENSMETER RL-10 (K925304)Canon USA, Inc.1994-02-17
OPTEC 3000 (K924741)Stereo Optical Co., Inc.1993-04-06
BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (K924778)R.H. Burton Co.1993-04-05
BURTON AUTO REFRACTOR - MODEL BAR-7 (K924790)R.H. Burton Co.1993-04-05
OPTEC 2300 AFVT, ARMED FORCES VISION TESTER (K904828)Stereo Optical Co., Inc.1991-01-18
AR-1600G AUTO-REFRACTOMETER (K902500)Nidek, Inc.1990-07-27
SHIN NIPPON AUTO REFRACTOMETER QR-007N (K901583)Soderberg, Inc.1990-06-22
NIDEK RT-1200S (MARCO TRS-1200) (K901513)Nidek, Inc.1990-06-08
NIDEK AR-1200 (K890559)Nidek, Inc.1989-02-27
CANON AUTOREFRACTOMETER R-22 (K883200)Canon USA, Inc.1988-08-18
CANON AUTOREFRACTOMETER R-20 (K882287)Canon USA, Inc.1988-07-01
NIDEK ARK-2000 (K882191)Nidek, Inc.1988-07-01
ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540 (K871611)Allergan Humphrey1987-05-18
BAUSCH & LOMB GR-3 REFRACTOR (K862521)Bausch & Lomb, Inc.1986-07-11
AR-1100 AUTOMATIC REFRACTOR (K861065)Nidek, Inc.1986-04-09
AR-1600 AUTOMATIC REFRACTOR (K861062)Nidek, Inc.1986-04-04
AR-1000 AUTOMATIC REFRACTOR (K861066)Nidek, Inc.1986-04-04
CANON AUTOREF R-10 (K841861)Canon USA, Inc.1984-10-05
VISION TESTER (K843042)Stereo Optical Co., Inc.1984-10-05
AUTO REFRACTOMETER (K831083)Nidek, Inc.1983-06-10
AUTOMATIC OBJECTIVE REFRACTOR 2000 (K820877)Dicon, Inc.1982-06-25
I.V.E. REFRACTION SYSTEM (K812896)Bausch & Lomb, Inc.1981-12-02
SR-1V DATA PRINTER (K812063)American Optical Corp.1981-08-18
SR-IV PROGRAMMED SUBJECTIVE REFRACTOR (K802183)American Optical Corp.1981-04-23
AUTO REFRACTOMETER NR-1000 (K802958)Nippon Kogaku, Inc.1981-04-23
OBJECTIVE REFRACTOR (K802029)Zeiss Humphrey System1980-11-12
DIOPTRON III AUTOREFRACTOR (K801906)Coherent Medical Division1980-08-27
AUTOREFRACTOR, SUBJECTIVE (K781014)Cavitron Corp.1978-09-07
SUBJECTIVE REFRACTOR, MOSEL SR-111 (K771914)American Optical Corp.1977-11-09

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