Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1850](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1850) → HJO — Biomicroscope, Slit-Lamp, Ac-Powered # HJO · Biomicroscope, Slit-Lamp, Ac-Powered _Ophthalmic · 21 CFR 886.1850 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO ## Overview - **Product Code:** HJO - **Device Name:** Biomicroscope, Slit-Lamp, Ac-Powered - **Regulation:** [21 CFR 886.1850](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1850) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **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](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K253834.md) | VISUREF 600 | Carl Zeiss Vision GmbH | Mar 18, 2026 | SESE | | [K231760](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K231760.md) | HP-OCT (HP-OCT) | Cylite Pty. , Ltd. | Mar 8, 2024 | SESE | | [K222372](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K222372.md) | Kowa SL-19 | Kowa Company , Ltd. | Nov 21, 2022 | SESE | | [K193188](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K193188.md) | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | Jan 14, 2020 | SESE | | [K182306](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K182306.md) | Sunkingdom Slit Lamp | Chongqing Sunkingdom Medical Instrument Co., Ltd. | Nov 22, 2018 | SESE | | [K173771](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K173771.md) | IOLMaster 700 | Carl Zeiss Meditec, AG | Aug 24, 2018 | SESE | | [K171877](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K171877.md) | SLM-1ER, SLM-2ER, SLM-3ER | Chongqing Kanghua Ruiming S&T Co., Ltd. | Dec 21, 2017 | SESE | | [K170470](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K170470.md) | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | Oct 6, 2017 | SESE | | [K162778](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K162778.md) | Portable Slit Lamp Microscope | Suzhou Kangjie Medical, Inc. | Jul 21, 2017 | SESE | | [K162684](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K162684.md) | SL 220 | Carl Zeiss Meditec, AG | May 31, 2017 | SESE | | [K163564](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K163564.md) | SLIT LAMP SL-2000 | Nidek Co., Ltd. | May 19, 2017 | SESE | | [K162636](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K162636.md) | Marco Ultra M3, Marco Ultra M4 | Takagi Seiko Co., Ltd. | Apr 14, 2017 | SESE | | [K170171](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K170171.md) | IOLMaster 700 | Carl Zeiss Meditec, AG | Apr 6, 2017 | SESE | | [K161607](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K161607.md) | VISULUX | Carl Zeiss Meditec, AG | Feb 23, 2017 | SESE | | [K161764](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K161764.md) | SLIT LAMP, Model: YF-100 | Chongqing Yeasn Science-Technology Co., Ltd. | Feb 16, 2017 | SESE | | [K161972](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K161972.md) | Slit Lamp SL-D301 | Topcon Corporation | Dec 9, 2016 | SESE | | [K160327](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K160327.md) | ALADDIN HW3.0 | Visia Imaging S.R.L. | Oct 5, 2016 | SESE | | [K153545](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K153545.md) | Portable Slit Lamp | Shanghai Bolan Optical-Electric Co., Ltd. | Jun 22, 2016 | SESE | | [K152535](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K152535.md) | Z5 Slit lamp microscope, Z2 Slit lamp microscope | Takagi Seiko Co., Ltd. | May 26, 2016 | SESE | | [K152429](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO/K152429.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com