MXK · Device, Analysis, Anterior Segment
Ophthalmic · 21 CFR 886.1850 · Class 2
Overview
| Product Code | MXK |
|---|---|
| Device Name | Device, Analysis, Anterior Segment |
| 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 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | Mar 13, 2026 | SESE |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | Dec 18, 2025 | SESE |
| K223700 | BOSS | Intelon Optics, Inc. | Aug 16, 2024 | SESE |
| K222933 | MYAH | Visia Imaging S.R.L. | Jun 29, 2023 | SESE |
| K211868 | MYAH | Visia Imaging S.R.L. | Mar 1, 2022 | SESE |
| K202989 | Myopia Master | Oculus Optikgeräte GmbH | Jul 14, 2021 | SESE |
| K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | Oct 21, 2020 | SESE |
| K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | Jul 25, 2019 | SESE |
| K191051 | ARGOS | Santec Corporation | May 16, 2019 | SESE |
| K152311 | Pentacam AXL | Oculus Optikgerate GmbH | Jan 20, 2016 | SESE |
| K150754 | ARGOS | Santec Corporation | Oct 2, 2015 | SESE |
| K073508 | PARKONE | Oculus Optikgerate GmbH | Sep 11, 2008 | SESE |
| K071183 | ALLEGRO OCULYZER | Wavelight AG | Jul 20, 2007 | SESE |
| K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | Heidelberg Engineering | Jan 13, 2006 | SESE |
| K051940 | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | Sis Ltd., Surgical Instrument Systems | Sep 28, 2005 | SESE |
| K041841 | PACHYCAM | Oculus Optikgerate GmbH | Jan 28, 2005 | SESE |
| K042742 | HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) | Heidelberg Engineering | Oct 13, 2004 | SESE |
| K031788 | PATHFINDER | Massie Research Laboratories, Inc. | Sep 2, 2004 | SESE |
| K040913 | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) | Bausch & Lomb | Jul 23, 2004 | SESE |
| K030393 | 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
