MXK
23 FDA 510(k) clearances · Product code
193 daysmedian time to decision
303 days90th percentile
23clearances measured
FDA profile
- Official device name
- Device, Analysis, Anterior Segment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Pentacam® Cornea OCT (K251848) | Oculus Optikgeräte GmbH | 2026-03-13 |
| Tomey Optical Biometer OA-2000 (OA-2000) (K252348) | Tomey Corporation | 2025-12-18 |
| BOSS™ (K223700) | Intelon Optics, Inc. | 2024-08-16 |
| MYAH (K222933) | Visia Imaging S.R.L. | 2023-06-29 |
| MYAH (K211868) | Visia Imaging S.R.L. | 2022-03-01 |
| Myopia Master (K202989) | Oculus Optikgeräte GmbH | 2021-07-14 |
| Pentacam AXL Wave (K201724) | Oculus Optikgerate GmbH | 2020-10-21 |
| Galilei G6 Lens Professional (K182659) | Sis Ag, Surgical Instrument Systems | 2019-07-25 |
| ARGOS (K191051) | Santec Corporation | 2019-05-16 |
| Pentacam AXL (K152311) | Oculus Optikgerate GmbH | 2016-01-20 |
| ARGOS (K150754) | Santec Corporation | 2015-10-02 |
| PARKONE (K073508) | Oculus Optikgerate GmbH | 2008-09-11 |
| ALLEGRO OCULYZER (K071183) | Wavelight AG | 2007-07-20 |
| HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) (K052935) | Heidelberg Engineering | 2006-01-13 |
| CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA (K051940) | Sis Ltd., Surgical Instrument Systems | 2005-09-28 |
| PACHYCAM (K041841) | Oculus Optikgerate GmbH | 2005-01-28 |
| HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) (K042742) | Heidelberg Engineering | 2004-10-13 |
| PATHFINDER (K031788) | Massie Research Laboratories, Inc. | 2004-09-02 |
| NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) (K040913) | Bausch & Lomb | 2004-07-23 |
| OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER (K030393) | Haag-Streit Holding AG | 2003-09-25 |
| PENTACAM SCHEIMPFLUG CAMERA (K030719) | Oculus Optikgerate GmbH | 2003-09-16 |
| ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM (K991284) | Nidek, Inc. | 1999-08-06 |
| ORBSCAN (K984443) | Technolas Perfect Vision GmbH | 1999-03-05 |
Track MXK automatically
Every clearance here is in the API, with alerts when new ones post.