Product code HLJ
- Device name
- Ophthalmoscope, Battery-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1570
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | Heine Optotechnik GmbH & Co. KG | 2015-05-18 |
| K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | Heine Optotechnik GmbH & Co. KG | 2015-01-29 |
| K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2014-03-07 |
| K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2013-12-04 |
| K131719 | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS | Medical Devices (Pvt) , Ltd. | 2013-10-30 |
| K123587 | HEINE MINI 3000 LED OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2013-03-22 |
| K093495 | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS | American Diagnostic Corp. | 2010-11-19 |
| K070270 | PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 | Kirchner & Wilhelm GmbH + Co.Kg | 2007-11-05 |
| K052599 | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A | Suzhou 66 Vision Tech Co., Ltd. | 2006-11-07 |
| K061278 | OPTYSE OPHTHALMOSCOPE | Ophthalmos , Ltd. | 2006-05-16 |
| K053425 | PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS | Precision Optics Corp. | 2006-01-09 |
| K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | Keeler Instruments, Inc. | 2003-11-26 |
| K002044 | MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT | Magna Fortis Corporation | 2000-09-12 |
| K962767 | MS401097-17,MS722-K,MS720,MS721,MS722 | Alexander Mfg. Co. | 1997-07-03 |
| K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 1997-04-02 |
| 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 |
| K950797 | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950796 | HALOGEN DIAGNOSTIC SET BX A - 12345 | Neitz Instruments Company, Ltd. | 1995-03-22 |
| K945640 | RI-SCOPE S OTOSCOPE | Rudolf Riester GmbH & Co. KG | 1995-01-17 |
| K944402 | FOCOMETER | Lacrimedics, Inc. | 1994-11-22 |
| K942721 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13 | Neitz Instruments Company, Ltd. | 1994-08-05 |
| K942719 | NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR | Neitz Instruments Company, Ltd. | 1994-08-05 |
| K942717 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A | Neitz Instruments Company, Ltd. | 1994-08-05 |
| K942034 | R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502 | R & D Batteries, Inc. | 1994-06-03 |
| K936018 | REPLACEMENT BATTERIES PART NO. 5098,5135, 5097 | R & D Batteries, Inc. | 1994-02-22 |
| K936104 | R & D BATTERIES | R & D Batteries, Inc. | 1994-02-22 |
| K925755 | DE LUXE | Rudolf Riester GmbH & Co. KG | 1993-12-03 |
| K925756 | UNI II | Rudolf Riester GmbH & Co. KG | 1993-10-18 |
| K932504 | RI-FORMER | Rudolf Riester GmbH & Co. KG | 1993-10-15 |
| K925757 | OPHTHALMOSCOPE | Rudolf Riester GmbH & Co. KG | 1993-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M368122741 | Labtron | GF HEALTH PRODUCTS, INC. | 2020-09-22 |
| M368122731 | Labtron | GF HEALTH PRODUCTS, INC. | 2020-09-22 |
| 00192896009585 | HEINE MPACK COMPLETE | SONTEC INSTRUMENTS, INC. | 2018-08-24 |
| 00192896009592 | HEINE LI-ION BATTERY | SONTEC INSTRUMENTS, INC. | 2018-08-24 |
| 00192896009578 | HEINE MPACK | SONTEC INSTRUMENTS, INC. | 2018-08-24 |
| 00192896009561 | HEINE HC 50 CONNECTING CORD | SONTEC INSTRUMENTS, INC. | 2018-08-24 |
| 00192896009554 | HEINE MPACK UNPLUGGED BATTERY | SONTEC INSTRUMENTS, INC. | 2018-08-24 |
| 00192896009547 | HEINE MPACK UNPLUGGED BATTERY | SONTEC INSTRUMENTS, INC. | 2018-08-24 |
| 00192896009530 | HEINE MPACK LL BATTERY PACK | SONTEC INSTRUMENTS, INC. | 2018-08-24 |
| 00192896009523 | HEINE MPACK MINI | SONTEC INSTRUMENTS, INC. | 2018-08-24 |
| 00192896009516 | HEINE - LITHIUM ION BATTERY | SONTEC INSTRUMENTS, INC. | 2018-08-24 |
| 00192896009509 | HEINE - BETA R HANDLE | SONTEC INSTRUMENTS, INC. | 2018-08-24 |
| 00634782083229 | Adstation™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782083212 | Adstation™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782083205 | Adstation™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782083199 | Adstation™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782083182 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782083175 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782071073 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782071059 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782064235 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782062057 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782062033 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782062026 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782053482 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782053475 | Proscope™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782053420 | Proscope™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782053413 | Proscope™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782040369 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782032937 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |