MXK
- Product code
- MXK
- Device name
- Device, Analysis, Anterior Segment
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.1850
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 23 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251848 | 2026-03-13 | Oculus Optikgeräte GmbH | Pentacam® Cornea OCT | |
| K252348 | 2025-12-18 | Tomey Corporation | Tomey Optical Biometer OA-2000 (OA-2000) | |
| K223700 | 2024-08-16 | Intelon Optics, Inc. | BOSS | FDA |
Official FDA classification page: MXK
Classification and pathway per current FDA publications. Data from openFDA (CC0).