Atlas FDA

HLQ

29 FDA 510(k) clearances · Product code

75 daysmedian time to decision
208 days90th percentile
29clearances measured

FDA profile

Official device name
Keratoscope, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.1350
Medical specialty
Ophthalmic
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RecordFirmDate
OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (K003299)Nidek Co., Ltd.2001-03-09
EYE SYS VISTA (K973756)Eyesys Technologies, Inc.1997-11-13
EYECHEK (K964290)Reichert Ophthalmic Instruments, Div. Leica, Inc.1997-01-09
TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (K945382)Expertech Assoc., Inc.1995-01-31
TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 (K944207)Computed Anatomy, Inc.1994-12-07
KERATRON CORNEAL TOPOGRAPHER (K944616)Alliance Medical Marketinig1994-11-22
ORBSCAN(TM) KERATOMETER (K940647)Orbtek, Inc.1994-07-06
EH-270 CORNEAL TOPOGRAPHER (K933556)Visioptic, Inc.1993-11-02
CORNEAL TOPOGRAPHY SYSTEM (K923435)Par Microsystems Corp.1993-02-16
KERATOREF L60 (K922253)Luneau Ophtalmologie SA1992-06-19
ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (K912740)Visionary Systems, Inc.1991-12-30
CCI VIDEOKERATOSCOPE/COMPARATOR (K913022)Cci1991-10-09
TBD KERATOSCOPE (K912130)Alcon Laboratories1991-08-09
CLAS PHOTOKERATOSCOPE (K895741)Kera-Metrics Corp.1990-07-11
VKS-1 VIDEO KERATOSCOPE (K902012)Computed Anatomy, Inc.1990-06-22
MODEL 2000 INTRAOPERATIVE CORNEASCOPE (K901009)Kera Corp.1990-05-30
TOPOGRAPHIC MODELING SYSTEM (K901363)Computed Anatomy, Inc.1990-05-25
CANON AUTO REF-KERATOMETER RK-2 (K895475)Canon USA, Inc.1989-10-31
ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER (K890687)Optimed, Inc.1989-09-05
CANON SURGICAL AUTO KERATOMETER SK-1 (K871936)Canon USA, Inc.1987-06-19
VIDEOSCAN (TM) (K871479)Kera Corp.1987-05-22
NIDEK KM-1000 SURGICAL KERATOMETER (K862137)Nidek, Inc.1986-07-23
NIDEK KM-800 AUTO KERATOMETER (K861063)Nidek, Inc.1986-04-04
ORC ORACLE (K853668)Optical Radiation Corp.1985-10-15
ZEISS OPERATING KERATOMETER (K853723)Carl Zeiss, Inc.1985-10-15
CORNEASCOPE MODEL 1200 (K850665)Kera Corp.1985-03-20
WOODLYN STANDARD SLIT LAMP HSSL-ST (K841765)Woodlyn, Inc.1984-08-07
SUN PHOTO-KERATOSCOPE (K831084)Nidek, Inc.1983-06-30
AUTOKERATOMETER, INSTRUMENT (K781994)Zeiss Humphrey System1979-02-12

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