MXK — Device, Analysis, Anterior Segment Class II
FDA product code MXK covers "Device, Analysis, Anterior Segment", a Class II medical device regulated under 21 CFR 886.1850. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MXK
- Device Class
- Class II
- Regulation Number
- 886.1850
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251848 | oculus optikgeräte | Pentacam® Cornea OCT | March 13, 2026 |
| K252348 | tomey corporation | Tomey Optical Biometer OA-2000 (OA-2000) | December 18, 2025 |
| K223700 | intelon optics | BOSS | August 16, 2024 |
| K222933 | visia imaging | MYAH | June 29, 2023 |
| K211868 | visia imaging | MYAH | March 1, 2022 |
| K202989 | oculus optikgeräte | Myopia Master | July 14, 2021 |
| K201724 | oculus optikgerate | Pentacam AXL Wave | October 21, 2020 |
| K182659 | sis ag, surgical instrument systems | Galilei G6 Lens Professional | July 25, 2019 |
| K191051 | santec corporation | ARGOS | May 16, 2019 |
| K152311 | oculus optikgerate | Pentacam AXL | January 20, 2016 |
| K150754 | santec corporation | ARGOS | October 2, 2015 |
| K073508 | oculus optikgerate | PARKONE | September 11, 2008 |
| K071183 | wavelight | ALLEGRO OCULYZER | July 20, 2007 |
| K052935 | heidelberg engineering | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | January 13, 2006 |
| K051940 | sis ltd., surgical instrument systems | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | September 28, 2005 |
| K041841 | oculus optikgerate | PACHYCAM | January 28, 2005 |
| K042742 | heidelberg engineering | HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) | October 13, 2004 |
| K031788 | massie research laboratories | PATHFINDER | September 2, 2004 |
| K040913 | bausch and lomb | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) | July 23, 2004 |
| K030393 | haag-streit holding | OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER | September 25, 2003 |