MXK — Device, Analysis, Anterior Segment Class II
FDA Device Classification
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 |