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) → MXK — Device, Analysis, Anterior Segment # MXK · Device, Analysis, Anterior Segment _Ophthalmic · 21 CFR 886.1850 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK ## Overview - **Product Code:** MXK - **Device Name:** Device, Analysis, Anterior Segment - **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 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251848](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K251848.md) | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | Mar 13, 2026 | SESE | | [K252348](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K252348.md) | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | Dec 18, 2025 | SESE | | [K223700](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K223700.md) | BOSS™ | Intelon Optics, Inc. | Aug 16, 2024 | SESE | | [K222933](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K222933.md) | MYAH | Visia Imaging S.R.L. | Jun 29, 2023 | SESE | | [K211868](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K211868.md) | MYAH | Visia Imaging S.R.L. | Mar 1, 2022 | SESE | | [K202989](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K202989.md) | Myopia Master | Oculus Optikgeräte GmbH | Jul 14, 2021 | SESE | | [K201724](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K201724.md) | Pentacam AXL Wave | Oculus Optikgerate GmbH | Oct 21, 2020 | SESE | | [K182659](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K182659.md) | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | Jul 25, 2019 | SESE | | [K191051](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K191051.md) | ARGOS | Santec Corporation | May 16, 2019 | SESE | | [K152311](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K152311.md) | Pentacam AXL | Oculus Optikgerate GmbH | Jan 20, 2016 | SESE | | [K150754](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K150754.md) | ARGOS | Santec Corporation | Oct 2, 2015 | SESE | | [K073508](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K073508.md) | PARKONE | Oculus Optikgerate GmbH | Sep 11, 2008 | SESE | | [K071183](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K071183.md) | ALLEGRO OCULYZER | Wavelight AG | Jul 20, 2007 | SESE | | [K052935](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K052935.md) | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | Heidelberg Engineering | Jan 13, 2006 | SESE | | [K051940](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K051940.md) | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | Sis Ltd., Surgical Instrument Systems | Sep 28, 2005 | SESE | | [K041841](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K041841.md) | PACHYCAM | Oculus Optikgerate GmbH | Jan 28, 2005 | SESE | | [K042742](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K042742.md) | HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) | Heidelberg Engineering | Oct 13, 2004 | SESE | | [K031788](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K031788.md) | PATHFINDER | Massie Research Laboratories, Inc. | Sep 2, 2004 | SESE | | [K040913](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K040913.md) | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) | Bausch & Lomb | Jul 23, 2004 | SESE | | [K030393](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK/K030393.md) | OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER | Haag-Streit Holding AG | Sep 25, 2003 | SESE | ## Top Applicants - Oculus Optikgerate GmbH — 5 clearances - Heidelberg Engineering — 2 clearances - Oculus Optikgeräte GmbH — 2 clearances - Santec Corporation — 2 clearances - Visia Imaging S.R.L. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MXK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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