FDA Product Code
FDA Product Code HLJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1570
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | Heine Optotechnik GmbH & Co. KG | 2015-05-18 | Abbreviated | PDF ↗ |
| K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | Heine Optotechnik GmbH & Co. KG | 2015-01-29 | Abbreviated | PDF ↗ |
| K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2014-03-07 | Abbreviated | PDF ↗ |
| K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2013-12-04 | Abbreviated | PDF ↗ |
| K131719 | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS | Medical Devices (Pvt) , Ltd. | 2013-10-30 | Traditional | PDF ↗ |
| K123587 | HEINE MINI 3000 LED OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2013-03-22 | Abbreviated | PDF ↗ |
| K093495 | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS | American Diagnostic Corp. | 2010-11-19 | Traditional | PDF ↗ |
| K070270 | PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 | Kirchner & Wilhelm GmbH + Co.Kg | 2007-11-05 | Traditional | PDF ↗ |
| K052599 | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A | Suzhou 66 Vision Tech Co., Ltd. | 2006-11-07 | Traditional | PDF ↗ |
| K061278 | OPTYSE OPHTHALMOSCOPE | Ophthalmos , Ltd. | 2006-05-16 | Abbreviated | PDF ↗ |
| K053425 | PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS | Precision Optics Corp. | 2006-01-09 | Traditional | PDF ↗ |
| K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | Keeler Instruments, Inc. | 2003-11-26 | Traditional | PDF ↗ |
| K002044 | MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT | Magna Fortis Corporation | 2000-09-12 | Traditional | PDF ↗ |
| K962767 | MS401097-17,MS722-K,MS720,MS721,MS722 | Alexander Mfg. Co. | 1997-07-03 | Traditional | PDF ↗ |
| K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K950914 | 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 | Rudolf Riester GmbH & Co. KG | 1995-07-24 | Traditional | PDF ↗ |
| K950797 | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | Neitz Instruments Company, Ltd. | 1995-03-28 | Traditional | PDF ↗ |
| K950796 | HALOGEN DIAGNOSTIC SET BX A - 12345 | Neitz Instruments Company, Ltd. | 1995-03-22 | Traditional | PDF ↗ |
| K945640 | RI-SCOPE S OTOSCOPE | Rudolf Riester GmbH & Co. KG | 1995-01-17 | Traditional | PDF ↗ |
| K944402 | FOCOMETER | Lacrimedics, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K942721 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13 | Neitz Instruments Company, Ltd. | 1994-08-05 | Traditional | PDF ↗ |
| K942719 | NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR | Neitz Instruments Company, Ltd. | 1994-08-05 | Traditional | PDF ↗ |
| K942717 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A | Neitz Instruments Company, Ltd. | 1994-08-05 | Traditional | PDF ↗ |
| K942034 | R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502 | R & D Batteries, Inc. | 1994-06-03 | Traditional | PDF ↗ |
| K936104 | R & D BATTERIES | R & D Batteries, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K936018 | REPLACEMENT BATTERIES PART NO. 5098,5135, 5097 | R & D Batteries, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K925755 | DE LUXE | Rudolf Riester GmbH & Co. KG | 1993-12-03 | Traditional | PDF ↗ |
| K925756 | UNI II | Rudolf Riester GmbH & Co. KG | 1993-10-18 | Traditional | PDF ↗ |
| K932504 | RI-FORMER | Rudolf Riester GmbH & Co. KG | 1993-10-15 | Traditional | PDF ↗ |
| K925757 | OPHTHALMOSCOPE | Rudolf Riester GmbH & Co. KG | 1993-08-03 | Traditional | PDF ↗ |
| K923543 | MIS | Ceram Optec, Inc. | 1993-03-29 | Traditional | PDF ↗ |
| K922910 | MEDICAL BATTERY PACKS | Access / God Loves You | 1992-09-30 | Traditional | PDF ↗ |
| K920272 | ORIEL | Truphatek, Ltd. | 1992-07-09 | Traditional | PDF ↗ |
| K896072 | D.L. SCOPE OPHTHALMOSCOPE | North American Medical Products, Inc. | 1989-11-27 | Traditional | PDF ↗ |
| K873987 | IRAS GLARE TESTER | Randwal Instrument Co., Inc. | 1987-11-24 | Traditional | PDF ↗ |
| K871735 | VOROSCOPE(TM) | Australian Biomedical Corporation , Ltd. | 1987-06-03 | Traditional | PDF ↗ |
| K853891 | INDIRECT OPHTHALMOSCOPE | Carl Zeiss, Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K852953 | #SM-3001 OPHTHA OTOSC SET SUBSETS SOLD | Design Med. Corp. | 1985-09-06 | Traditional | PDF ↗ |
| K852334 | MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) | Design Med. Corp. | 1985-06-18 | Traditional | PDF ↗ |
| K843897 | POCKET OPHTHALMOSCOPE GH | Design Med. Corp. | 1984-11-27 | Traditional | PDF ↗ |
| K842567 | PORTABLE ACUIOMETER | Randwal Instrument Co., Inc. | 1984-08-15 | Traditional | PDF ↗ |
| K841292 | SPECTACLE INDIRECT OPHTHALMOSCOPE | Keller Instruments, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K832437 | MEDIC LUX DIAGNOSTIC SETS | Keeler Instruments, Inc. | 1983-08-16 | Traditional | PDF ↗ |
| K830215 | DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP | Jedmed Instrument Co. | 1983-03-09 | Traditional | PDF ↗ |
| K780215 | EYESCOPE | Visual Methods, Inc. | 1978-04-10 | Traditional | PDF ↗ |
| K760771 | SOLA SCHULTZE-CROCK OPTHALMOSCOPE | Codman & Shurtleff, Inc. | 1976-10-15 | Traditional | PDF ↗ |
| K760770 | SOLA COMMIDO LOUPE | Codman & Shurtleff, Inc. | 1976-10-15 | Traditional | PDF ↗ |
Product code HLJ · Class II · Ophthalmic. Data: openFDA.