Product code HJO
- Device name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1850
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | 2026-03-18 |
| K231760 | HP-OCT (HP-OCT) | Cylite Pty. , Ltd. | 2024-03-08 |
| K222372 | Kowa SL-19 | Kowa Company , Ltd. | 2022-11-21 |
| K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2020-01-14 |
| K182306 | Sunkingdom Slit Lamp | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2018-11-22 |
| K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018-08-24 |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ER | Chongqing Kanghua Ruiming S&T Co., Ltd. | 2017-12-21 |
| K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2017-10-06 |
| K162778 | Portable Slit Lamp Microscope | Suzhou Kangjie Medical, Inc. | 2017-07-21 |
| K162684 | SL 220 | Carl Zeiss Meditec, AG | 2017-05-31 |
| K163564 | SLIT LAMP SL-2000 | Nidek Co., Ltd. | 2017-05-19 |
| K162636 | Marco Ultra M3, Marco Ultra M4 | Takagi Seiko Co., Ltd. | 2017-04-14 |
| K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017-04-06 |
| K161607 | VISULUX | Carl Zeiss Meditec, AG | 2017-02-23 |
| K161764 | SLIT LAMP, Model: YF-100 | Chongqing Yeasn Science-Technology Co., Ltd. | 2017-02-16 |
| K161972 | Slit Lamp SL-D301 | Topcon Corporation | 2016-12-09 |
| K160327 | ALADDIN HW3.0 | Visia Imaging S.R.L. | 2016-10-05 |
| K153545 | Portable Slit Lamp | Shanghai Bolan Optical-Electric Co., Ltd. | 2016-06-22 |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | Takagi Seiko Co., Ltd. | 2016-05-26 |
| K152429 | Slit Lamp Microscope | Shanghai Mediworks Precision Instruments Co. , Ltd. | 2016-05-11 |
| K151394 | Keeler Slit Lamp | Keeler Limited | 2015-09-10 |
| K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015-07-10 |
| K141954 | XCEL 455 SLIT LAMP | Reichert, Inc. | 2014-10-15 |
| K141068 | ZEISS CATARACT SUITE MARKERLESS | Carl Zeiss Meditec, AG | 2014-09-09 |
| K133667 | SLIT LAMP SL-D701 | Topcon Corp. | 2014-08-26 |
| K140451 | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) | Keeler Limited | 2014-07-11 |
| K133062 | DISCOVERY SYSTEM | Innovative Visual Systems | 2014-06-20 |
| K133132 | OPTICAL BIOMETER AL-SCAN | Nidek Co., Ltd. | 2014-06-11 |
| K131567 | ALADDIN | Visia Imaging S.R.L. | 2014-06-05 |
| K131711 | YZ3 PORTABLE SLIT LAMP | Suzhou 66 Vision Tech Co., Ltd. | 2014-05-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06951090800978 | 66VT | 66 VISION TECH CO., LTD. | 2026-04-27 |
| 04250668607202 | VISUREF 600 | Carl Zeiss Vision GmbH | 2026-04-24 |
| 04049471097153 | SL 220 | Carl Zeiss Meditec AG | 2026-01-13 |
| 00852194002137 | SL-5000 | Hightech American Industrial Labs Inc | 2025-12-18 |
| 04547451338321 | INAMI | INAMI & CO., LTD. | 2025-08-29 |
| 00840124520776 | PolyLock Small Bone | FUSION ORTHOPEDICS, LLC | 2025-05-19 |
| 00819034023240 | TalarLift | FUSION ORTHOPEDICS, LLC | 2025-05-19 |
| 00840124520738 | PolyLock Small Bone | FUSION ORTHOPEDICS, LLC | 2025-05-19 |
| 00840124520745 | PolyLock Small Bone | FUSION ORTHOPEDICS, LLC | 2025-05-19 |
| 00840124520752 | PolyLock Small Bone | FUSION ORTHOPEDICS, LLC | 2025-05-19 |
| 00840124520769 | PolyLock Small Bone | FUSION ORTHOPEDICS, LLC | 2025-05-19 |
| 04987669200636 | Image filing software NAVIS-EX | NIDEK CO.,LTD. | 2023-06-12 |
| 04987646810223 | KOWA SL-19 | KOWA COMPANY,LTD. | 2023-01-10 |
| 04580606432024 | Visionix | RIGHT MFG. CO., LTD. | 2023-01-05 |
| 04580606432055 | Visionix | RIGHT MFG. CO., LTD. | 2023-01-05 |
| M6333974310 | JEDMED | JEDMED INSTRUMENT COMPANY | 2022-12-19 |
| 04049584025357 | Pentacam AXL Wave | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2021-11-03 |
| 04987669101452 | Ophthalmic YAG Laser System | NIDEK CO.,LTD. | 2021-09-24 |
| 04987669101650 | YAG laser combination delivery unit (YC-200) | NIDEK CO.,LTD. | 2021-09-24 |
| 06973211070374 | Ophthalmic Slit Lamp Microscope | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD | 2020-07-02 |
| 06973211070381 | Ophthalmic Slit Lamp Microscope | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD | 2020-07-02 |
| 04573344510024 | OPTICAL BIOMETER | SANTEC CORPORATION | 2019-05-22 |
| 08034028770333 | ALADDIN HW3.0 | VISIA IMAGING SRL | 2016-12-14 |
| 08034028770203 | ALADDIN HW3.0 | VISIA IMAGING SRL | 2016-11-03 |
| 08034028770180 | ALADDIN TMS | VISIA IMAGING SRL | 2016-09-26 |
| 00380656786108 | Alcon | Alcon Laboratories, Inc. | 2016-09-24 |
| 00859623006612 | LIPIVIEW II OCULAR SURFACE INTERFEROMETE | TEARSCIENCE, INC. | 2016-09-23 |
| 00859623006513 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | TEARSCIENCE, INC. | 2016-09-23 |
| 04987669100523 | Image filing software | NIDEK CO.,LTD. | 2016-08-26 |
| 08056098470012 | LUMENIS | COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL | 2016-08-03 |