510(k) K251848
- Device
- Pentacam® Cornea OCT
- Applicant
- Oculus Optikgeräte GmbH
- 510(k) number
- K251848
- Product code
- MXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-13
- Date received
- 2025-06-16
- Regulation
- 886.1850
- Classification name
- Device, Analysis, Anterior Segment
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Agata Kufel
- Address
- Muencholzhaeuserstrasse 29 Wetzlar DE 35582 35582
FDA Registration Numbers#
- 3003771740
- 3007913988
- 3020723591
- 1920664
- 3004858034
- 3008729548
- 3009173773
- 9614661
- 3009298127
- 3033566
- 9611269
- 3012423824
- 3009217531
- 3004441848
- 8020986
- 3010227033
- 3035545084
- 8043762
Source Documents#
Other 510(k) Records For Product Code MXK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | 2025-12-18 |
| K223700 | BOSS™ | Intelon Optics, Inc. | 2024-08-16 |
| K222933 | MYAH | Visia Imaging S.R.L. | 2023-06-29 |
| K211868 | MYAH | Visia Imaging S.R.L. | 2022-03-01 |
| K202989 | Myopia Master | Oculus Optikgeräte GmbH | 2021-07-14 |
| K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | 2020-10-21 |
| K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | 2019-07-25 |
| K191051 | ARGOS | Santec Corporation | 2019-05-16 |
| K152311 | Pentacam AXL | Oculus Optikgerate GmbH | 2016-01-20 |
| K150754 | ARGOS | Santec Corporation | 2015-10-02 |
| K073508 | PARKONE | Oculus Optikgerate GmbH | 2008-09-11 |
| K071183 | ALLEGRO OCULYZER | Wavelight AG | 2007-07-20 |
| K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | Heidelberg Engineering | 2006-01-13 |
| K051940 | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | Sis Ltd., Surgical Instrument Systems | 2005-09-28 |
| K041841 | PACHYCAM | Oculus Optikgerate GmbH | 2005-01-28 |