HJO · Biomicroscope, Slit-Lamp, Ac-Powered
Ophthalmic · 21 CFR 886.1850 · Class 2
Overview
| Product Code | HJO |
|---|---|
| Device Name | Biomicroscope, Slit-Lamp, Ac-Powered |
| Regulation | 21 CFR 886.1850 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.
Classification Rationale
Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Recent Cleared Devices (20 of 108)
Showing 20 most recent of 108 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | Mar 18, 2026 | SESE |
| K231760 | HP-OCT (HP-OCT) | Cylite Pty. , Ltd. | Mar 8, 2024 | SESE |
| K222372 | Kowa SL-19 | Kowa Company , Ltd. | Nov 21, 2022 | SESE |
| K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | Jan 14, 2020 | SESE |
| K182306 | Sunkingdom Slit Lamp | Chongqing Sunkingdom Medical Instrument Co., Ltd. | Nov 22, 2018 | SESE |
| K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | Aug 24, 2018 | SESE |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ER | Chongqing Kanghua Ruiming S&T Co., Ltd. | Dec 21, 2017 | SESE |
| K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | Oct 6, 2017 | SESE |
| K162778 | Portable Slit Lamp Microscope | Suzhou Kangjie Medical, Inc. | Jul 21, 2017 | SESE |
| K162684 | SL 220 | Carl Zeiss Meditec, AG | May 31, 2017 | SESE |
| K163564 | SLIT LAMP SL-2000 | Nidek Co., Ltd. | May 19, 2017 | SESE |
| K162636 | Marco Ultra M3, Marco Ultra M4 | Takagi Seiko Co., Ltd. | Apr 14, 2017 | SESE |
| K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | Apr 6, 2017 | SESE |
| K161607 | VISULUX | Carl Zeiss Meditec, AG | Feb 23, 2017 | SESE |
| K161764 | SLIT LAMP, Model: YF-100 | Chongqing Yeasn Science-Technology Co., Ltd. | Feb 16, 2017 | SESE |
| K161972 | Slit Lamp SL-D301 | Topcon Corporation | Dec 9, 2016 | SESE |
| K160327 | ALADDIN HW3.0 | Visia Imaging S.R.L. | Oct 5, 2016 | SESE |
| K153545 | Portable Slit Lamp | Shanghai Bolan Optical-Electric Co., Ltd. | Jun 22, 2016 | SESE |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | Takagi Seiko Co., Ltd. | May 26, 2016 | SESE |
| K152429 | Slit Lamp Microscope | Shanghai Mediworks Precision Instruments Co. , Ltd. | May 11, 2016 | SESE |
Top Applicants
- Carl Zeiss Meditec, AG — 8 clearances
- Bausch & Lomb, Inc. — 4 clearances
- Carl Zeiss, Inc. — 4 clearances
- R.H. Burton Co. — 4 clearances
- Haag-Streit AG — 3 clearances
