510(k) K222372
- Device
- Kowa SL-19
- Applicant
- Kowa Company, Ltd.
- 510(k) number
- K222372
- Product code
- HJO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-21
- Date received
- 2022-08-05
- Regulation
- 886.1850
- Classification name
- Biomicroscope, Slit-lamp, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code HJO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262637 | SLIT LAMP SL-D4 (Type: LED) | Topcon Corporation | 2026-09-18 |
| K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | 2026-03-18 |
| K231760 | HP-OCT (HP-OCT) | Cylite Pty. , Ltd. | 2024-03-08 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases