Pachycam
FDA 510(k) K041841 · Oculus Optikgerate GmbH
510(k) numberK041841
Submission
- Device name
- Pachycam
- Applicant
- Oculus Optikgerate GmbH
Wetzla-Dutenhofen, DE - Received
- July 8, 2004
- Decision date
- January 28, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXK – Device, Analysis, Anterior Segment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
Other 510(k)s with product code MXK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251848 | Pentacam® Cornea OCTMXK · Traditional | Oculus Optikgeräte GmbH | 03/13/2026SE |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000)MXK · Traditional | Tomey Corporation | 12/18/2025SE |
| K223700 | BossMXK · Traditional | Intelon Optics, Inc. | 08/16/2024SE |
| K222933 | MyahMXK · Traditional | Visia Imaging S.R.L. | 06/29/2023SE |
| K211868 | MyahMXK · Traditional | Visia Imaging S.R.L. | 03/01/2022SE |
| K202989 | Myopia MasterMXK · Traditional | Oculus Optikgeräte GmbH | 07/14/2021SE |
| K201724 | Pentacam AXL WaveMXK · Traditional | Oculus Optikgerate GmbH | 10/21/2020SE |
| K182659 | Galilei G6 Lens ProfessionalMXK · Traditional | Sis Ag, Surgical Instrument Systems | 07/25/2019SE |
| K191051 | ArgosMXK · Traditional | Santec Corporation | 05/16/2019SE |
| K152311 | Pentacam AXLMXK · Traditional | Oculus Optikgerate GmbH | 01/20/2016SE |
More from Oculus Optikgerate GmbH
Questions and answers
When was Pachycam cleared by the FDA?
Pachycam (K041841) received a 510(k) decision of Substantially Equivalent on January 28, 2005, 204 days after the submission was received.
What is the product code of K041841?
The FDA product code is MXK – Device, Analysis, Anterior Segment, a Class II (moderate risk) device regulated under 21 CFR 886.1850.