Device, Analysis, Anterior Segment
The Anterior Segment Analysis Device is an ophthalmic diagnostic instrument used to examine and measure structures of the anterior segment of the eye, including the cornea, anterior chamber, iris, and lens. It supports clinical assessment for conditions such as keratoconus, glaucoma, and pre-surgical evaluation for refractive or cataract procedures. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 886.1850 (Ophthalmic specialty). This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- MXK
- Device Class
- FDA class 2
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251848 | Pentacam® Cornea OCT | Mar 13, 2026 | Substantially Equivalent | Oculus Optikgeräte GmbH |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Dec 18, 2025 | Substantially Equivalent | Tomey Corporation |
| K223700 | BOSS | Aug 16, 2024 | Substantially Equivalent | Intelon Optics, Inc. |
| K222933 | MYAH | Jun 29, 2023 | Substantially Equivalent | Visia Imaging S.R.L. |
| K211868 | MYAH | Mar 01, 2022 | Substantially Equivalent | Visia Imaging S.R.L. |
| K202989 | Myopia Master | Jul 14, 2021 | Substantially Equivalent | Oculus Optikgeräte GmbH |
| K201724 | Pentacam AXL Wave | Oct 21, 2020 | Substantially Equivalent | Oculus Optikgerate GmbH |
| K182659 | Galilei G6 Lens Professional | Jul 25, 2019 | Substantially Equivalent | Sis Ag, Surgical Instrument Systems |
| K191051 | ARGOS | May 16, 2019 | Substantially Equivalent | Santec Corporation |
| K152311 | Pentacam AXL | Jan 20, 2016 | Substantially Equivalent | Oculus Optikgerate GmbH |
| K150754 | ARGOS | Oct 02, 2015 | Substantially Equivalent | Santec Corporation |
| K073508 | PARKONE | Sep 11, 2008 | Substantially Equivalent | Oculus Optikgerate GmbH |
| K071183 | ALLEGRO OCULYZER | Jul 20, 2007 | Substantially Equivalent | Wavelight AG |
| K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | Jan 13, 2006 | Substantially Equivalent | Heidelberg Engineering |
| K051940 | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | Sep 28, 2005 | Substantially Equivalent | Sis Ltd., Surgical Instrument Systems |
| K041841 | PACHYCAM | Jan 28, 2005 | Substantially Equivalent | Oculus Optikgerate GmbH |
| K042742 | HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) | Oct 13, 2004 | Substantially Equivalent | Heidelberg Engineering |
| K031788 | PATHFINDER | Sep 02, 2004 | Substantially Equivalent | Massie Research Laboratories, Inc. |
| K040913 | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) | Jul 23, 2004 | Substantially Equivalent | Bausch & Lomb |
| K030393 | OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER | Sep 25, 2003 | Substantially Equivalent | Haag-Streit Holding AG |
| K030719 | PENTACAM SCHEIMPFLUG CAMERA | Sep 16, 2003 | Substantially Equivalent | Oculus Optikgerate GmbH |
| K991284 | ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM | Aug 06, 1999 | Substantially Equivalent | Nidek, Inc. |
| K984443 | ORBSCAN | Mar 05, 1999 | Substantially Equivalent | Technolas Perfect Vision GmbH |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.