Atlas FDA

HLJ

47 FDA 510(k) clearances · Product code

62 daysmedian time to decision
339 days90th percentile
47clearances measured

FDA profile

Official device name
Ophthalmoscope, Battery-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1570
Medical specialty
Ophthalmic
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RecordFirmDate
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 (K142486)Heine Optotechnik GmbH & Co. KG2015-05-18
HEINE SIGMA 250 & HEINE SIGMA 250 M2 (K142837)Heine Optotechnik GmbH & Co. KG2015-01-29
HEINE MINI 3000(R) OPHTHALMOSCOPE (K131959)Heine Optotechnik GmbH & Co. KG2014-03-07
HEINE BETA 200(R) OPHTHALMOSCOPE (K131961)Heine Optotechnik GmbH & Co. KG2013-12-04
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS (K131719)Medical Devices (Pvt) , Ltd.2013-10-30
HEINE MINI 3000 LED OPHTHALMOSCOPE (K123587)Heine Optotechnik GmbH & Co. KG2013-03-22
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (K093495)American Diagnostic Corp.2010-11-19
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 (K070270)Kirchner & Wilhelm GmbH + Co.Kg2007-11-05
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A (K052599)Suzhou 66 Vision Tech Co., Ltd.2006-11-07
OPTYSE OPHTHALMOSCOPE (K061278)Ophthalmos , Ltd.2006-05-16
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS (K053425)Precision Optics Corp.2006-01-09
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (K032087)Keeler Instruments, Inc.2003-11-26
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT (K002044)Magna Fortis Corporation2000-09-12
MS401097-17,MS722-K,MS720,MS721,MS722 (K962767)Alexander Mfg. Co.1997-07-03
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE (K970029)Keeler Instruments, Inc.1997-04-02
RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V (K950914)Rudolf Riester GmbH & Co. KG1995-07-24
HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 (K950797)Neitz Instruments Company, Ltd.1995-03-28
HALOGEN DIAGNOSTIC SET BX A - 12345 (K950796)Neitz Instruments Company, Ltd.1995-03-22
RI-SCOPE S OTOSCOPE (K945640)Rudolf Riester GmbH & Co. KG1995-01-17
FOCOMETER (K944402)Lacrimedics, Inc.1994-11-22
NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR (K942719)Neitz Instruments Company, Ltd.1994-08-05
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13 (K942721)Neitz Instruments Company, Ltd.1994-08-05
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A (K942717)Neitz Instruments Company, Ltd.1994-08-05
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502 (K942034)R & D Batteries, Inc.1994-06-03
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097 (K936018)R & D Batteries, Inc.1994-02-22
R & D BATTERIES (K936104)R & D Batteries, Inc.1994-02-22
DE LUXE (K925755)Rudolf Riester GmbH & Co. KG1993-12-03
UNI II (K925756)Rudolf Riester GmbH & Co. KG1993-10-18
RI-FORMER (K932504)Rudolf Riester GmbH & Co. KG1993-10-15
OPHTHALMOSCOPE (K925757)Rudolf Riester GmbH & Co. KG1993-08-03
MIS (K923543)Ceram Optec, Inc.1993-03-29
MEDICAL BATTERY PACKS (K922910)Access / God Loves You1992-09-30
ORIEL (K920272)Truphatek, Ltd.1992-07-09
D.L. SCOPE OPHTHALMOSCOPE (K896072)North American Medical Products, Inc.1989-11-27
IRAS GLARE TESTER (K873987)Randwal Instrument Co., Inc.1987-11-24
VOROSCOPE(TM) (K871735)Australian Biomedical Corporation , Ltd.1987-06-03
INDIRECT OPHTHALMOSCOPE (K853891)Carl Zeiss, Inc.1985-10-04
#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD (K852953)Design Med. Corp.1985-09-06
MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) (K852334)Design Med. Corp.1985-06-18
POCKET OPHTHALMOSCOPE GH (K843897)Design Med. Corp.1984-11-27
PORTABLE ACUIOMETER (K842567)Randwal Instrument Co., Inc.1984-08-15
SPECTACLE INDIRECT OPHTHALMOSCOPE (K841292)Keller Instruments, Inc.1984-05-09
MEDIC LUX DIAGNOSTIC SETS (K832437)Keeler Instruments, Inc.1983-08-16
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP (K830215)Jedmed Instrument Co.1983-03-09
EYESCOPE (K780215)Visual Methods, Inc.1978-04-10
SOLA COMMIDO LOUPE (K760770)Codman & Shurtleff, Inc.1976-10-15
SOLA SCHULTZE-CROCK OPTHALMOSCOPE (K760771)Codman & Shurtleff, Inc.1976-10-15

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